Dade Behring, Inc.
Medical device manufacturer in Newark, DE.
343510(k) clearances
1PMA approvals
5recalls
Device types
- LON System, Test, Automated, Antimicrobial… 37
- JIT Calibrator, Secondary 29
- LRG Instrument For Auto Reader & Interpretation… 23
- JIX Calibrator, Multi-Analyte Mixture 18
- JPA System, Multipurpose For In Vitro… 12
- GKP Instrument, Coagulation, Automated 9
- JWY Manual Antimicrobial Susceptibility Test… 8
- JJY Multi-Analyte Controls, All Kinds (Assayed) 8
- DLJ Calibrators, Drug Specific 8
- MMI Immunoassay Method, Troponin Subunit 7
- CFN Method, Nephelometric, Immunoglobulins (G… 6
- DAP Fibrinogen And Fibrin Split Products… 6
- JIS Calibrator, Primary 6
- NBC Test, Natriuretic Peptide 6
- DDG Transferrin, Antigen, Antiserum, Control 5
- LTT Panels, Test, Susceptibility, Antimicrobial 5
- NQD Cardiac C-Reactive Protein, Antigen… 5
- DKB Calibrators, Drug Mixture 5
- DKZ Enzyme Immunoassay, Amphetamine 5
- MKW Cyclosporine 4
510(k) clearances (latest 300)
| 510(k) | Device | Decision |
|---|---|---|
| K093848 | Pt-Multi-Calibrator, Model OPAT07GGN · Traditional | 12/20/2010SE |
| K081161 | Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…CFN · Traditional | 07/28/2008SE |
| K081249 | Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…DEB · Traditional | 07/21/2008SE |
| K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)DHX · Traditional | 06/25/2008SE |
| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | 06/04/2008SE |
| K073604 | Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…CEC · Traditional | 03/13/2008SE |
| K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…CFN · Traditional | 02/26/2008SE |
| K073072 | Dimension Ahdl Flex Reagent Cartridge, Model: DF48BJHM · Traditional | 02/21/2008SE |
| K073055 | Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270JFY · Traditional | 01/03/2008SE |
| K072965 | Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDBA · Traditional | 12/21/2007SE |
| K072717 | Dimension Vista System Bilirubin Calibrator, Model KC210JIT · Traditional | 12/12/2007SE |
| K071224 | Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 CalibratorCDD · Traditional | 11/13/2007SE |
| K072435 | Dimension Vista Protein 3 Calibrator, 3 CONTROL,1 Control L, 1 Control M, 1 Control HJIX · Traditional | 10/17/2007SE |
| K072304 | Fibrinogen Calibrator KitGFX · Traditional | 09/19/2007SE |
| K071980 | Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,HJJY · Traditional | 09/11/2007SE |
| K071811 | Etoh Flex Reagent Cartridge (DF22)DIC · Traditional | 08/24/2007SE |
| K071317 | Microscan Synergies Plus Gram Positive Mic/Combo Panels New Antimicrobial-Gentamicin…LON · Traditional | 08/20/2007SE |
| K071316 | Microscan Synergies Plus Gram Positive Mic/Combo Panels New Antimicrobial-Streptomycin…LRG · Traditional | 08/20/2007SE |
| K071834 | Stratus CS Acute Care Nt-Probnp Testpak, Model CpbnpmNBC · Traditional | 08/17/2007SE |
| K071247 | N Latex RF KitDHR · Traditional | 08/08/2007SE |
| K071767 | Dimensions PBNP Flex Reagent Cartridge, Model RF423ANBC · Traditional | 08/04/2007SE |
| K070346 | Dade Behring Labpro Alert Software SystemLON · Traditional | 07/18/2007SE |
| K071268 | Microscan Synergies Plus Gram Positive Mic/Combo Panels with TetracyclineLON · Traditional | 06/26/2007SE |
| K070853 | Dimension Vista Etoh Flex Reagent Cartridge, Model K5022DIC · Traditional | 06/13/2007SE |
| K071076 | Synergies Plus Gram-Positive Mic/Combo PanelsLON · Traditional | 05/21/2007SE |
| K070860 | Microscan Synergies Plus Gram-Positive Mic/Combo Panels with ClindamycinLON · Traditional | 05/11/2007SE |
| K070552 | Dimension Vista Ferritin Flex Reagent Cartridge (Ferr)JIT · Traditional | 04/30/2007SE |
| K063356 | Stratus CS Acute Care D-Dimer Testpak, Dilpak, CalpakDAP · Traditional | 03/23/2007SE |
| K063663 | Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…DDG · Traditional | 03/21/2007SE |
| K063756 | Dimension Vista Ctni Flex Reagent CartridgeMMI · Traditional | 03/19/2007SE |
| K063754 | Dimension Vista (TM) BHCG Flex(R) Reagent Cartridge, and BHCG Calibrator, Model#…DHA · Traditional | 02/23/2007SE |
| K063608 | Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…MSJ · Traditional | 02/23/2007SE |
| K063655 | Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…CHN · Traditional | 02/15/2007SE |
| K063425 | Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…DGC · Traditional | 02/15/2007SE |
| K063564 | Microscan Synergies Plus Gram-Positive Mic/Combo Panels with Chloramphenicol (4-16 Ug/Ml)LON · Traditional | 02/08/2007SE |
| K063272 | Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium…JZG · Traditional | 01/26/2007SE |
| K063322 | Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control…DDG · Traditional | 01/24/2007SE |
| K063508 | Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…JIX · Traditional | 01/23/2007SE |
| K063351 | Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin Control…NDY · Traditional | 01/22/2007SE |
| K063610 | Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium…DEM · Traditional | 01/11/2007SE |
| K063206 | Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control…LPS · Traditional | 12/28/2006SE |
| K062924 | Stratus CS Acute Care Cardiophase Hscrp TestpakNQD · Traditional | 12/26/2006SE |
| K063366 | Microscan Synergies Plus Gram-Positive Mic/Combo Panel with Synercid (0.12-2UG/ML…LON · Traditional | 12/08/2006SE |
| K063365 | Synergies Plus Gram-Positive Mic/Combo Panels with Gentamicin (0.06-32MG/ML Long…LON · Traditional | 12/08/2006SE |
| K063299 | Microscan Microstrep Plus Panel-ClarithromycinLRG · Traditional | 11/27/2006SE |
| K062938 | Microscan Synergies Plus Gram-Positive Mic/Combo Panels with Nitrofurantoin (2 - 256 Ug/MlLON · Traditional | 11/20/2006SE |
| K063102 | Microscan Microstrep Plus Panel Cefaclor (0.5 - 8 Mcg/Ml)LRG · Traditional | 11/09/2006SE |
| K063101 | Microscan Microstrep Plus Panel Cefotaxime (0.015 - 8 Mcg/MlLRG · Traditional | 11/01/2006SE |
| K063099 | Microscan Microstrep Plus Panel Cefepime (O.015 - 8 Mcg/Ml)LRG · Traditional | 11/01/2006SE |
| K063065 | Microscan Microstrep Plus Panel Meropenem (0.03-4MCG/ML)LRG · Traditional | 10/27/2006SE |
| K063064 | Microscan Microstrep Plus Panel Ceftriaxone (0.015-8MCG/ML)LRG · Traditional | 10/26/2006SE |
| K063053 | Microscan Microstrep Plus Panel Cefuroxime (0.12-8 Mcg/Ml)LRG · Traditional | 10/26/2006SE |
| K062375 | Microscan Microstrep Plus Panel Erythromycin (0.015 to 2 Mcg/Ml)LRG · Traditional | 10/26/2006SE |
| K062705 | Synergies Plus Gram-Positive Mic/Combo Panels with LinezolidLON · Traditional | 10/20/2006SE |
| K062923 | Microscan Microstrep Plus Panel Tetracycline (0.006 to 16 Mcg/Ml)LRG · Traditional | 10/13/2006SE |
| K062773 | Microscan Microstrep Plus Panel, PenicillinLTT · Traditional | 10/13/2006SE |
| K062927 | Microscan Microstrep Plus Panel Ampicillin (0.013 - 16 Mcg/Ml)LRG · Traditional | 10/12/2006SE |
| K062777 | Microscan Microstrep Plus Panel, ClindamycinLTT · Traditional | 10/10/2006SE |
| K062035 | Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and ControlJIX · Traditional | 10/04/2006SE |
| K062334 | Dimension Vista Chemistry 3 Calibrator, Model KC130JIX · Traditional | 09/22/2006SE |
| K061852 | Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low…CZW · Traditional | 09/22/2006SE |
| K062596 | Microstrep Plus Panel Amoxicillin/Clavulanic AcidLRG · Traditional | 09/19/2006SE |
| K062585 | Microscan Microstrep Plus Panel AzithromycinLRG · Traditional | 09/19/2006SE |
| K061990 | Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…DCF · Traditional | 09/19/2006SE |
| K062182 | Dimension Vista System Ecstasy Calibrator, Model KC520DLJ · Traditional | 09/14/2006SE |
| K062162 | Dimension Vista System Drugs of Abuse Calibrator (Udat Cal - KC510)DKB · Traditional | 09/14/2006SE |
| K061802 | Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp…NQD · Traditional | 09/11/2006SE |
| K061795 | Dimension Vista PBNP Flex Reagent Cartridge and CalibratorNBC · Traditional | 09/11/2006SE |
| K062316 | Dimension Vista Ammonia (Amon) Flex Reagent CartridgeJIF · Special | 09/06/2006SE |
| K062199 | Dimension Vista System Drug 3 Calibrator (Drug 3 Cal - KC430)DLJ · Traditional | 09/06/2006SE |
| K062034 | Dimension Vista System Drug 1 Calibrator (Drug 1 Cal - KC410)JIX · Traditional | 09/06/2006SE |
| K061825 | Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and…DCN · Traditional | 09/06/2006SE |
| K062290 | Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 Mcg/Ml)LRG · Traditional | 09/01/2006SE |
| K061839 | Dimension Vista Dbil Flex Reagent Cartridge, Model K2125CIG · Traditional | 08/29/2006SE |
| K062122 | Dimension Vista System Chemistry 3 Calibrator (Chem 3 Cal - KC130)JIX · Traditional | 08/25/2006SE |
| K062121 | Dimension Vista System Drug 2 Calibrator (Drug 2 Cal - KC420)DKB · Traditional | 08/25/2006SE |
| K061923 | Dimension Vista Enzyme 1 Calibrator (Enz 1 Cal - KC310)JIX · Traditional | 08/25/2006SE |
| K061719 | Dimension Vista Tbil Flex Reagent Cartridge, and Dimension Vista Tbil/Dbil Calibrator…CIG · Traditional | 08/25/2006SE |
| K060677 | N Latex CDTNAO · Traditional | 08/25/2006SE |
| K062293 | Microscan Microstrep Plus Panel Chloramphenicol (1 to 32 Mcg/Ml)LRG · Traditional | 08/24/2006SE |
| K061845 | Dimension Vista Igm Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and HCFN · Traditional | 08/24/2006SE |
| K062276 | Microscan Microstrep Plus PanelLRG · Traditional | 08/23/2006SE |
| K062179 | Microscan Dried Gram-Positive Mic/Combo Panels with Erythromycin (0.25 - 16UG/ML)LRG · Special | 08/23/2006SE |
| K061872 | Microscan Microstrep Plus PanelLRG · Traditional | 08/23/2006SE |
| K062236 | Dimension Vista Cyclosporine (Csa) Flex Reagent CartridgeMKW · Special | 08/21/2006SE |
| K062191 | Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models KC515 and…DIF · Traditional | 08/21/2006SE |
| K062128 | The Dimension Vista Flex Reagent Cartridges / Kit AssaysJHS · Special | 08/21/2006SE |
| K061838 | Dimension Vista Chemistry 1 Calibrator, Model KC110JIX · Traditional | 08/21/2006SE |
| K062152 | Creatinine Kinase MB Isoenzyme Verifier, Model DC27JIT · Traditional | 08/16/2006SE |
| K061885 | Dimension Vista System Total Triiodothyronine Calibrator, Model KC250JIT · Traditional | 08/14/2006SE |
| K061750 | Dimension Vista System Lipid Calibrator, Model KC220JIX · Traditional | 08/11/2006SE |
| K062055 | Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighJIX · Traditional | 08/07/2006SE |
| K061793 | Dimension Vista Iron Flex Reagent Cartridge and CalibratorJIY · Special | 08/07/2006SE |
| K061703 | Dimension Vista Chemistry 2 Calibrator (Chem 2 Cal, KC120)JIX · Traditional | 08/02/2006SE |
| K062024 | Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin…LFM · Special | 07/28/2006SE |
| K061687 | Microscan Dried Gram Negative Mic/Combo PanelsJWY · Traditional | 07/21/2006SE |
| K060489 | Dade PFA-100 Platelet Function Analyzer and ReagentsJOZ · Traditional | 07/21/2006SE |
| K061818 | Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330)JIT · Traditional | 07/18/2006SE |
| K061792 | Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex…DIC · Special | 07/18/2006SE |
| K061536 | Microscan Dried Gram Negative Mic/Combo PanelsJWY · Traditional | 07/18/2006SE |
| K061751 | Dimension Vista System Ucfp Calibrator, Model KC260JIT · Traditional | 07/13/2006SE |
| K061702 | Dimension Vista System Creatine Kinase Calibrator (CK Cal - KC340)JIT · Traditional | 07/10/2006SE |
| K061655 | Dimension Vista Flex Reagent CartridgesLDP · Special | 07/10/2006SE |
| K061338 | Dimension Vista Iga Flex Reagent Cartridge AssayCFN · Traditional | 07/06/2006SE |
| K061390 | Dimension Vista System ENZYME2 Calibrator, Model KC320JIX · Traditional | 07/05/2006SE |
| K061218 | Dimension Vista System Chemistry Calibrator 4, Model KC140JIX · Traditional | 06/30/2006SE |
| K061503 | Dimension Cyclosporine Extended Range Calibrator (DC108A)DLJ · Traditional | 06/22/2006SE |
| K061251 | Dimension Vista Total Iron Binding Capacity CalibratorJIS · Traditional | 05/31/2006SE |
| K061238 | Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent…KHS · Special | 05/25/2006SE |
| K053337 | Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109DKZ · Traditional | 05/19/2006SE |
| K060503 | Dimension Tacr Calibrator, Model DC107DLJ · Traditional | 05/18/2006SE |
| K060502 | Dimension Tacr Flex Reagent Cartridge, Model DF107MLM · Traditional | 05/18/2006SE |
| K061020 | Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…CKA · Special | 05/10/2006SE |
| K060369 | Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, DilpakNQD · Traditional | 05/04/2006SE |
| K053577 | Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample DiluentMMI · Traditional | 04/14/2006SE |
| K060628 | Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi CalibratorCIG · Special | 04/06/2006SE |
| K060548 | Stratus CS Acute Care Betahcg and Nt-Probnp Testpak and Testpak Assay, Calpak and DilpakDHA · Traditional | 04/06/2006SE |
| K060385 | Emit 2000 Tacrolimus Assay and Sample Pretreatment ReagentMLM · Traditional | 04/06/2006SE |
| K052788 | N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/HLPS · Traditional | 03/29/2006SE |
| K053073 | N Antisera to Human ALPHA2-MACROGLOBULINDEB · Traditional | 03/28/2006SE |
| K053072 | N Antisera to Human ALPHA1-ANTITRYPSINDEM · Traditional | 03/28/2006SE |
| K060312 | Microscan Synergies Plus Gram-Positive Mic/Combo Panels with Vancomycin (0.25-64 Ug/Ml)LON · Traditional | 03/23/2006SE |
| K053075 | N Antisera to Human TransferrinDDG · Traditional | 03/16/2006SE |
| K053074 | N Antisera to Human CeruloplasminDDB · Traditional | 03/16/2006SE |
| K060371 | The Emit 2000 Tacrolimus CalibratorsJIT · Traditional | 03/09/2006SE |
| K060266 | Dimension Iron CalibratorJIS · Traditional | 03/09/2006SE |
| K060264 | Dimension Iron Flex Reagent Cartridge (IRON-DF85)JIY · Traditional | 03/08/2006SE |
| K053531 | Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 CalibratorCEC · Traditional | 03/03/2006SE |
| K060090 | Dimension Vista Thyroid Stimulating Hormone Flex Reagent CartridgeJLW · Traditional | 02/27/2006SE |
| K053504 | Microscan Synergies Plus Gram-Positive Mic/Combo Panels with Erythromycin (0.12-16 Ug/Ml)LON · Traditional | 02/24/2006SE |
| K053108 | Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108DLJ · Traditional | 02/16/2006SE |
| K053576 | Dimension Vista Myo Reagent Cartridge and CalibratorJIT · Traditional | 02/07/2006SE |
| K053061 | Emit 2000 Cyclosporine Specific AssayMKW · Traditional | 02/06/2006SE |
| K060088 | Microscan Synergies Plus Gram Positive Mic/Combo Panels - AmpicillinLON · Traditional | 02/03/2006SE |
| K053109 | Dimension Cardiophase High Sensitivity CRP Flex Reagent CartridgeNQD · Traditional | 12/23/2005SE |
| K053104 | Dimension Cardiophase High Sensitivity C-Reactive Protein CalibratorJIS · Traditional | 12/23/2005SE |
| K053157 | Automated HDL Cholesterol Flex Reagent Cartridge, Model DF48ALBS · Special | 12/09/2005SE |
| K052346 | Synergies Plus Gram-Positive Mic/Combo PanelsLON · Traditional | 10/26/2005SE |
| K052015 | Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108DLJ · Traditional | 09/12/2005SE |
| K051650 | Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute…JHX · Traditional | 09/08/2005SE |
| K052017 | Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108MKW · Traditional | 09/01/2005SE |
| K051597 | Stratus CS D-DimerDAP · Traditional | 08/17/2005SE |
| K051478 | Microscan Synergies Plus Gram Positive Mic/Combo Panels - RifampinLON · Traditional | 07/27/2005SE |
| K051350 | Synergies Plus Gram-Positive Mic/Combo PanelsLON · Traditional | 07/25/2005SE |
| K051311 | Microscan Synergies Plus Gram Positive Minimum Inhibitory Concentration/Combo Panels -…LON · Traditional | 07/12/2005SE |
| K051087 | Dimension Vista Integrated SystemJJE · Traditional | 07/11/2005SE |
| K050928 | Dade Thrombin ReagentKQJ · Traditional | 06/29/2005SE |
| K051202 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 06/23/2005SE |
| K050665 | N Antisera to Human Complement Factors (C3C, C4)CZW · Traditional | 05/02/2005SE |
| K050043 | Microscan Dried Gram-Positive Mic/Combo Panels with ErythromycinLRG · Traditional | 03/29/2005SE |
| K050585 | Microscan Dried Gram Negative Mic/Combo Panels Amoxicillin/K. ClavulanateLRG · Special | 03/18/2005SE |
| K043545 | Microscan Dried Gram-Positive Mic/Combo Panels with Daptomycin (0.03 - 16 Mcg/Ml)LRG · Traditional | 02/17/2005SE |
| K043476 | Stratus CS Acute Care Nt-Probnp Testpak, PBNP Calpak Calibrator, PBNP Dilpak DiluentNBC · Traditional | 02/15/2005SE |
| K042735 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm)CFN · Traditional | 02/15/2005SE |
| K043546 | Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer ModuleCDT · Special | 01/18/2005SE |
| K043028 | Emit II Plus Ecstasy AssayDKZ · Traditional | 01/07/2005SE |
| K042687 | Enzygnost F+2 (Monoclonal) Test KitMIF · Traditional | 12/10/2004SE |
| K042941 | Dade Behring Heparin Calibrator and ControlsGIZ · Traditional | 12/02/2004SE |
| K042333 | Control Plasma N, Proc Control PlasmaGGN · Traditional | 12/01/2004SE |
| K042347 | Modification to Dimension Nt-Probnp Flex Reagent Cartridge MethodNBC · Traditional | 11/19/2004SE |
| K042407 | Emit Caffeine AssayKLS · Traditional | 10/28/2004SE |
| K042209 | Control Plasma N and Control Plasma PGGN · Traditional | 10/21/2004SE |
| K041878 | N Latex CystatinNDY · Traditional | 08/16/2004SE |
| K041438 | Advanced D-Dimer AssayDAP · Traditional | 08/11/2004SE |
| K041870 | N Apolipoprotein Standard SerumJIX · Traditional | 07/27/2004SE |
| K041150 | Microscan Synergies Plus Gram-Negative Mic/Combo PanelsLRG · Traditional | 07/22/2004SE |
| K041417 | Dimension Nt-Probnp Flex Reagent Cartridge Method, Dimension PBNP Calibrator, Models…NBC · Traditional | 07/20/2004SE |
| K040133 | Urine Amphetamine/Methamphetamine Screen Flex Reagent CartridgeDKZ · Traditional | 04/08/2004SE |
| K031601 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Cephalothin (0.5-32 Ug/Ml)LON · Traditional | 04/02/2004SE |
| K033948 | Microscan Dried Gram-Negative Mic/Combo Panels (Gemifloxacin)LRG · Traditional | 03/01/2004SE |
| K033940 | Microscan Dried Gram-Negative Mic/Combo Panels-Amoxicillin/Clavulanate Potassium…LTT · Traditional | 02/25/2004SE |
| K033809 | Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II…KLR · Traditional | 02/20/2004SE |
| K032706 | Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 Mcg/MlJWY · Traditional | 02/10/2004SE |
| K033713 | Urine Cocaine Metabolite Screen Flex Reagent Cartridge, Catalog# DF92ADIO · Traditional | 02/09/2004SE |
| K033908 | N High Sensitivity CRPNQD · Traditional | 01/22/2004SE |
| K033525 | Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114…DCF · Traditional | 01/12/2004SE |
| K033487 | Stratus CS Acute Care Troponin I Testpak, Model CctniMMI · Traditional | 12/24/2003SE |
| K033482 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Ampicillin (0.25-128 Ug/Ml)LON · Special | 11/26/2003SE |
| K032697 | Dimension Total Triiodothyronine Calibrator (RC414)JIS · Traditional | 11/07/2003SE |
| K032573 | Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110LAR · Traditional | 10/31/2003SE |
| K032564 | Dimension N-Acetylprocainamide (Napa) Flex Reagent Cartridge Method, Model DF111LAN · Traditional | 10/31/2003SE |
| K032798 | Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48AJHM · Traditional | 10/30/2003SE |
| K032574 | Dimension Drug Calibrator II, Model DC49CDKB · Traditional | 10/06/2003SE |
| K031377 | Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…GKP · Traditional | 09/08/2003SE |
| K032237 | N/T Protein ControlJJY · Traditional | 09/05/2003SE |
| K032014 | N Latex IgmCFN · Traditional | 08/07/2003SE |
| K031602 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Nitrofurantoin (1-256 Ug/Ml)LON · Traditional | 07/31/2003SE |
| K031512 | Emit II Plus Cocaine Metabolite AssayDIO · Traditional | 07/23/2003SE |
| K031004 | Syva Emit II Plus Amphetamines AssayDKZ · Traditional | 06/06/2003SE |
| K031135 | Glucose Flex Reagent Cartridge (Gluc)CFR · Traditional | 06/02/2003SE |
| K031343 | Tpsa Flex Reagent CartridgeLTJ · Special | 05/15/2003SE |
| K024038 | N Latex IgaCZP · Traditional | 02/13/2003SE |
| K023141 | Modification to Standard Human PlasmaJPA · Traditional | 01/16/2003SE |
| K022976 | Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-DDAP · Traditional | 01/16/2003SE |
| K023361 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Gatifloxacin (0.004-16 Ug/Ml)LON · Traditional | 12/16/2002SE |
| K023541 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Moxifloxacin (0.004-16UG/ML)LON · Traditional | 12/13/2002SE |
| K022977 | Stratus CS D-Dimer Calpak Calibrator, Model Cddmr-CDAP · Traditional | 11/27/2002SE |
| K023312 | Control Plasma PGGC · Traditional | 11/01/2002SE |
| K023309 | Control Plasma NGIZ · Traditional | 11/01/2002SE |
| K023065 | Cyclosporine (Csa) Flex Reagent CartridgeMKW · Traditional | 10/16/2002SE |
| K022290 | Protein S AcGGP · Traditional | 08/27/2002SE |
| K020413 | Microscan Synergies Plus Dried Gram Negative Mic/Combo Panels with Ceftazidime (1-16…LON · Traditional | 07/17/2002SE |
| K020979 | Sysmex Automated Coagulation Analyzer, Model #CA-7000GKP · Traditional | 06/27/2002SE |
| K020980 | Dimension Tpsa Calibrator, Model #RC459JIT · Traditional | 06/21/2002SE |
| K020410 | Microscan Rapid/S Plus Gram-Negative Mic/Combo Panels with Cephalothin (2-64 Ug/Ml)LON · Traditional | 06/11/2002SE |
| K021381 | Modification to N/T Rheumatology Controls SL 1 & 2JJY · Traditional | 06/10/2002SE |
| K020398 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Ampicillin (0.25-128 Ug/Ml)LON · Traditional | 05/16/2002SE |
| K020692 | Emit 2000 Vancomycin AssayLEH · Traditional | 05/10/2002SE |
| K020820 | Microscan Microstep Plus Panel New Antimicrobial - CefuroximeJWY · Traditional | 05/09/2002SE |
| K020724 | Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131MRR · Traditional | 05/09/2002SE |
| K020845 | Emit 2000 Vancomycin CalibratorsDLJ · Traditional | 05/08/2002SE |
| K020822 | Microscan Microstep Plus Panel New Antimicrobial - VancomycinJWY · Traditional | 05/08/2002SE |
| K020723 | Dimension Aldl Calibrator, Model DC131JIT · Traditional | 05/08/2002SE |
| K021037 | Microstrep Plus Panel with AmpicillinJWY · Traditional | 05/06/2002SE |
| K020397 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Piperacillin (4-256 Ug/Ml)LON · Traditional | 04/22/2002SE |
| K020319 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Ampicillin/Sulbactam…LON · Traditional | 04/17/2002SE |
| K020441 | Emit II Plus Monoclonal Cocaine Metabolite AssayDIO · Traditional | 03/28/2002SE |
| K020248 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with…LON · Traditional | 03/14/2002SE |
| K020162 | Dried Gram-Positive Mic/Combo Panels with PenicillinJWY · Traditional | 03/14/2002SE |
| K020160 | Dried Gram-Positive Mic/Combo Panels with AmpicillinLTT · Traditional | 03/14/2002SE |
| K020142 | Microscan Synergies PlusLON · Traditional | 03/14/2002SE |
| K020328 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Cefuroxime (1-64 Ug/Ml)LON · Traditional | 02/19/2002SE |
| K020249 | Microscan Plus Gram Negative Mic/Combo Panels with Meropenem (0.12-32 Ug/Ml)LON · Traditional | 02/06/2002SE |
| K020246 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Imipenem (0.25, 1-32 Ug/Ml)LON · Traditional | 02/06/2002SE |
| K020209 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Amikacin (0.25-128 Ug/Ml)LON · Traditional | 02/06/2002SE |
| K020185 | Microscan Rapid/S Plus Gram-Negative Mic Combo Panels with Gentamicin (0.12-32 Ug/Ml)LON · Traditional | 02/06/2002SE |
| K020182 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Netilmicin (0.12-32 Ug/Ml)LON · Traditional | 02/06/2002SE |
| K020173 | Microscan Synergies Plus Gram Negative Mic/Combo Panels with Tetracycline (0.12-128 Ug/Ml)LON · Traditional | 02/06/2002SE |
| K020168 | Microscan Synergis Plus Gram Negative Mic/Combo Panels with Tobramycin (0.12-32 Ug/Ml)LON · Traditional | 02/06/2002SE |
| K013155 | Dade Thromboplastin C PlusGJS · Traditional | 01/18/2002SE |
| K013128 | N Latex Lp(A)DFC · Traditional | 01/18/2002SE |
| K011852 | Dimension Haic Assay, Model DF105LCP · Traditional | 11/15/2001SE |
| K013126 | N Lp(A) Standard SyJIS · Traditional | 11/09/2001SE |
| K013114 | BCS SystemJPA · Traditional | 11/09/2001SE |
| K013130 | N Lp(A) Control SyJJX · Traditional | 10/18/2001SE |
| K012470 | Modification to N Protein Standard SLJIX · Traditional | 09/28/2001SE |
| K012233 | Stratus CS Troponin I CalibratorJIT · Traditional | 09/11/2001SE |
| K012468 | Modification to N/T Protein Control SLJJY · Traditional | 09/04/2001SE |
| K010418 | Dried Gram-Negative and Gram-Positive Mic/Combo PanelsLTT · Traditional | 08/22/2001SE |
| K011665 | BCT SystemJPA · Traditional | 08/09/2001SE |
| K011235 | Sysmex Automated Coagulation Analyzer / Model # CA-1500JPA · Traditional | 07/20/2001SE |
| K011112 | Cyclosporine CalibratorDLJ · Traditional | 07/17/2001SE |
| K010871 | TGL Flex Reagent CartridgeCDT · Traditional | 07/09/2001SE |
| K002885 | Dade PFA-100 Platelet Function Analyzer MODEL-100, Dade Pfa Collegen/Epinephrine Test…JOZ · Traditional | 06/21/2001SE |
| K011035 | Dimension Drug Calibrator, Model DC22BJIX · Traditional | 06/14/2001SE |
| K011033 | Dimension Lithium (Li) Flex Reagent Cartridge, Model DF 132JIH · Traditional | 06/07/2001SE |
| K010494 | Sysmex Automated Coagulation Analyzer, Model CA-1500JPA · Traditional | 05/01/2001SE |
| K010314 | Dimension Ctni CalibratorJIT · Traditional | 04/20/2001SE |
| K010313 | Dimension Ctni Flex Reagent CartridgeMMI · Traditional | 04/20/2001SE |
| K010206 | Dimension Enzymatic Carbonate (ECO2) Flex Method, Catalog DF137KHS · Traditional | 03/16/2001SE |
| K003501 | N Protein Standard Uy CalibratorJIT · Traditional | 03/15/2001SE |
| K010061 | Dimension Clinical Chemistry System, Model XpandCEM · Traditional | 03/14/2001SE |
| K003503 | N Latex Cystatin CNDY · Traditional | 03/13/2001SE |
| K003963 | Dimension Psa Flex Reagent CartridgeLTJ · Traditional | 02/28/2001SE |
| K010208 | Dimension Enzymatic Carbonate (ECO2) Calibrator, Catalog DC137JIT · Traditional | 02/20/2001SE |
| K003870 | Thromborel SGJS · Traditional | 02/20/2001SE |
| K003419 | RCRP Flex Reagent CartridgeDCN · Traditional | 02/14/2001SE |
| K003696 | Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg, BHCG…DHA · Traditional | 01/25/2001SE |
| K003209 | Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog No. DF93ADJG · Traditional | 12/05/2000SE |
| K002852 | N/T Protein Control SLJJY · Traditional | 11/27/2000SE |
| K002731 | N Latex B2-MICROGLOBULINJZG · Traditional | 11/20/2000SE |
| K002080 | Behring Coagulation System, Model BCSJPA · Traditional | 11/16/2000SE |
| K002974 | Emit Tox Acetaminophen Assay, Model 7A319UL; Emit Tox Ecetaminophen Calibrators, Model…LDP · Traditional | 10/11/2000SE |
| K002551 | Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4G019UL, 4G109ULLEG · Traditional | 10/11/2000SE |
| K002804 | N Protein Standard SLJIX · Traditional | 10/05/2000SE |
| K002541 | Protein C ReagentGGP · Traditional | 09/26/2000SE |
| K001647 | BN Prospec SystemJZW · Traditional | 09/26/2000SE |
| K001645 | Sysmex Automated Coagulation Analyzer, Model CA-1500GKP · Traditional | 08/04/2000SE |
| K001064 | Behring Coagulation Timer Analyzer (BCT)JPA · Traditional | 06/21/2000SE |
| K001067 | Dade Behring Coagulation Analyzer (BCT)JPA · Traditional | 06/20/2000SE |
| K000973 | Behring Coagulation System (BCS)JPA · Traditional | 05/26/2000SE |
| K001256 | Control Plasma NGIZ · Traditional | 05/24/2000SE |
| K001145 | Sysmex Automated Coagulation Analyzer, Model CA-6000GKP · Traditional | 05/11/2000SE |
| K000649 | Sysmex Automated Coagulation Analyzer, Model CA-1500GGP · Traditional | 04/25/2000SE |
| K000458 | Urine Benzodiazepines (Benz) Screen Flex Reagent Cartridge, Catalog No. DF 92AJXM · Traditional | 04/17/2000SE |
| K000467 | Urine Cocaine Metabolite (Coc) Screen Flex Reagent Cartridge, Catalog No. DF 92ADIO · Traditional | 04/14/2000SE |
| K000464 | Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog No. DF 90ADJG · Traditional | 04/14/2000SE |
| K000460 | Urine Amphetamine/Methamphetamine (Amph) Screen Flex Reagent, Catalog No. DF 90ADKZ · Traditional | 04/14/2000SE |
| K000462 | Urine Phencyclidine (PCP) Screen Flex Reagent Cartridge, Catalog No. DF 94ALCM · Traditional | 04/06/2000SE |
| K000461 | Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog No. DF 95ALDJ · Traditional | 04/06/2000SE |
| K000466 | Urine Methadone (Meth) Screen Flex Reagent Cartridge, Catalog No. DF 93ADJR · Traditional | 04/05/2000SE |
| K000459 | Urine Barbiturates (Barb) Screen Flex Reagent Cartridge, Catalog No. DF 96ADIS · Traditional | 04/03/2000SE |
| K994341 | Fibrinogen Calibrator KitGFX · Traditional | 03/03/2000SE |
| K994296 | Dimension C3 Flex Reagent CartridgeCZW · Traditional | 03/01/2000SE |
| K994293 | Dimension C4 Flex Reagent CartridgeDBI · Traditional | 03/01/2000SE |
| K994291 | Dimension Special Protein CalibratorJIT · Traditional | 03/01/2000SE |
| K994294 | Dimension TRNF Flex Reagent CartridgeDDG · Traditional | 02/04/2000SE |
| K994115 | Total Iron Binding Capacity (Ibct) Flex Reagent CartridgeJMO · Traditional | 01/28/2000SE |
| K992957 | Advanced D-DimerDAP · Traditional | 01/28/2000SE |
| K994114 | Dimension Total Iron Binding Capacity (Ibct) CalibratorJIS · Traditional | 01/20/2000SE |
| K992959 | Behring Coagulation System (BCS)JPA · Traditional | 01/11/2000SE |
| K993299 | Sysmex Automated Coagulation Analyzer, Model CA-1500GKP · Traditional | 12/07/1999SE |
| K993310 | Apolipoprotein Control Serum CHD, Model OuphJJY · Traditional | 11/30/1999SE |
| K993273 | N Latex FerritinDBF · Traditional | 11/23/1999SE |
| K993174 | Sysmex Automated Coagulation Analyzer, Model CA-6000GKP · Traditional | 11/09/1999SE |
| K991385 | Dade Behring N High Sensitivity CRP AssayDCK · Traditional | 10/25/1999SE |
| K992763 | Sysmex Automated Coagulation Analyzer, Model CA-500GKP · Traditional | 09/21/1999SE |
| K992423 | Sysmex Automated Coagulation Analyzer, Model CA-500GKP · Traditional | 09/21/1999SE |
| K992321 | Sysmex Automated Coagulation Analyzer, Model CA-6000GKP · Traditional | 09/17/1999SE |
| K991157 | N Latex STFR ReagentDDG · Traditional | 08/02/1999SE |
PMA approvals
- P920031 Emit 2000 Cyclosporine Specific Assay · 10/02/1996 · 3 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0581-2009 | Dimension EXL Clinical Chemistry System used with software versions 8.5.1 and 8.5.1SP3.…Error messages, "Wash Aspirator Failure" and "Wash station unable to recover" are not generated when one or… | 09/30/2008Terminated |
| Z-0485-2009 | Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in…Reagent may exhibit unflagged inaccurate patient sample results. | 09/29/2008Terminated |
| Z-0668-2009 | Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.Incorrect result: Potential for false elevation of CTnI results | 06/23/2008Terminated |
| Z-1174-2007 | EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING…Sample ID and Patient results could be associated with the wrong patient | 07/03/2007Terminated |
| Z-0247-2007 | Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;Product does not meet performance specifications through its standardized inocula for MicroScan Dried… | 09/27/2006Terminated |