Sigma Diagnostics, Inc.
Medical device manufacturer in St. Louis, MO.
164510(k) clearances
0PMA approvals
0recalls
Device types
- JPA System, Multipurpose For In Vitro… 8
- LJG Quality Control Slides 7
- CDQ Urease And Glutamic Dehydrogenase, Urea… 5
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 4
- DAP Fibrinogen And Fibrin Split Products… 4
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 4
- GJT Plasma, Coagulation Factor Deficient 4
- CHH Enzymatic Esterase--Oxidase, Cholesterol 3
- JIX Calibrator, Multi-Analyte Mixture 3
- JIT Calibrator, Secondary 3
- JJX Single (Specified) Analyte Controls… 3
- JFL Ph Rate Measurement, Carbon-Dioxide 3
- CFR Hexokinase, Glucose 3
- GGN Plasma, Coagulation Control 3
- CGX Alkaline Picrate, Colorimetry, Creatinine 3
- DLJ Calibrators, Drug Specific 3
- KXT Enzyme Immunoassay, Digoxin 3
- CJY Azo Dye, Calcium 2
- CGA Glucose Oxidase, Glucose 2
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K021162 | Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-Eu, Amax Destiny…JPA · Traditional | 08/30/2002SE |
| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | 02/06/2002SE |
| K013549 | Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971DAP · Traditional | 12/26/2001SE |
| K013545 | Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional | 11/15/2001SE |
| K013544 | Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096DAP · Traditional | 11/15/2001SE |
| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional | 03/30/2001SE |
| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
| K003328 | Accuclot Control I, Model A4089GIZ · Traditional | 03/01/2001SE |
| K001403 | Sigma Diagnostics Infinity Glucose Reagent, Models 17-25, 17-100P, 17-500P, 17-2000P…CFR · Traditional | 08/10/2000SE |
| K993741 | Ez LDL Cholesterol Test SystemMRR · Traditional | 07/03/2000SE |
| K001569 | Infinity Amylase Reagent (Procedure No. 580/568)JFJ · Traditional | 06/26/2000SE |
| K000528 | Accuclot Drvvt Confirm, Catalog No. A62119GIR · Traditional | 04/07/2000SE |
| K000527 | Accuclot Drvvt Screen, Catalog No. A6094GIR · Traditional | 04/07/2000SE |
| K992712 | Sigma Diagnostics Alexin LS, Models A1219, A1334GFO · Traditional | 12/06/1999SE |
| K992711 | Sigma Diagnostics Alexin HS, Models A0969, A1094GFO · Traditional | 12/06/1999SE |
| K992801 | Sigma Diagnostics Infinity Astbun Reagent, Model 51-25, Sigma Diagnostics Infinity Ast…CIT · Traditional | 09/28/1999SE |
| K992800 | Sigma Diagnostics Infinity Bun Reagent, Models 63-25, 63-100P, 63-500P, 63-2000P, 64-20…CDQ · Traditional | 09/28/1999SE |
| K992798 | Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P…CDO · Traditional | 09/28/1999SE |
| K992803 | Sigma Diagnostics Infinity Cholesterol Reagent, Models 401-25, 401-100P, 401-500P…CHH · Traditional | 09/13/1999SE |
| K984574 | Infinity Glucose ReagentCFR · Traditional | 02/11/1999SE |
| K982209 | Accuclot Thrombin Time Reagent Model A8713/A4589GJA · Traditional | 10/15/1998SE |
| K982251 | Sigma Diagnostics Infinity Uric Acid Reagent KitCDO · Traditional | 08/18/1998SE |
| K982236 | Sigma Diagnostics Infinity Bun Reagent KitCDQ · Traditional | 08/05/1998SE |
| K981255 | Sigma Diagnostics Accuclot Control IIIGGN · Traditional | 04/29/1998SE |
| K981254 | Sigma Diagnostics Accuclot Control IIGGN · Traditional | 04/29/1998SE |
| K981248 | Sigma Diagnostics Accuclot Control IGGN · Traditional | 04/29/1998SE |
| K980667 | Infinity Cholesterol Reagent (Procedure No. 401)CHH · Traditional | 04/21/1998SE |
| K980666 | Infinity Ast Reagent (Procedure No. 51)CIT · Traditional | 03/20/1998SE |
| K973274 | Accucolor High Calibrator (A3089)GIZ · Traditional | 10/31/1997SE |
| K972260 | CS-400 Coagulation Analyzer System (A1208)JPA · Traditional | 10/20/1997SE |
| K972796 | Sigma Diagnostics Thrombomax with CalciumGJS · Traditional | 10/10/1997SE |
| K971858 | Sigma Diagnostics Fibrinogen Kit (886A/887A)KQJ · Traditional | 10/09/1997SE |
| K972743 | Sigma Diagnostics Creatinine Reagent, Sigma Diagnostics Creatinine ReagentCGX · Traditional | 09/22/1997SE |
| K972794 | Digoxin Dg-Ii Fpia Reagent SetKXT · Traditional | 07/31/1997SE |
| K972132 | Sigma Diagnostics Valproic Acid Fpia Reagent Set, Sigma Diagnostics Valproic Acid Fpia…LEG · Traditional | 07/30/1997SE |
| K972144 | Sigma Diagnostics Accucolor Antithrombin IIIJBQ · Traditional | 07/25/1997SE |
| K972041 | Ez HDL Cholesterol Reagent(Procedure 354)/EZ HDL Calibrator (354-5)LBS · Traditional | 07/22/1997SE |
| K963535 | Sigma Diagnostics Glucose ReagentCGA · Traditional | 01/17/1997SE |
| K963539 | Sigma Diagnostics Wash ConcentrateJJE · Traditional | 12/16/1996SE |
| K963543 | Sigma Diagnostics CX -3 Calibration Standard, Level 2JIX · Traditional | 10/30/1996SE |
| K963533 | Sigma Diagnostic CX -3 Calibration Standard Level 1JIX · Traditional | 10/29/1996SE |
| K963541 | Sigma Diagnostics CO2 Acid ReagentJFL · Traditional | 10/24/1996SE |
| K963537 | Sigma Diagnostics Bun ReagentLFP · Traditional | 10/24/1996SE |
| K963538 | Sigma Diagnostics CO2ALKALINE BufferJFL · Traditional | 10/11/1996SE |
| K963536 | Sigma Diagnostics Calicium ReagentCJY · Traditional | 10/10/1996SE |
| K963534 | Sigma Diagnostics Creatinine Reagent KitCGX · Traditional | 09/30/1996SE |
| K963542 | Sigma Diagostic Electrolyte Reference ReagentJGS · Traditional | 09/27/1996SE |
| K963540 | Sigma Diagnostics Electrolyte BufferJFL · Traditional | 09/27/1996SE |
| K960875 | KC 40 Micro Coagulation Analyzer System (K3632)JPA · Traditional | 09/10/1996SE |
| K955720 | Amax CS-190 Coagulation Analyzer SystemJPA · Traditional | 03/13/1996SE |
| K955724 | KC 1A Coagulation Analyzer/SetJPA · Traditional | 03/12/1996SE |
| K955735 | KC 4A Micro Coagulation Analyzer Set/SystemJPA · Traditional | 03/11/1996SE |
| K954840 | Alkaline Phosphatase (Alp) Procedure No. 245CJE · Traditional | 02/28/1996SE |
| K955716 | Vancomycin Fpia Reagent SetLEH · Traditional | 02/16/1996SE |
| K952557 | Total T-3 Fpia Reagent Set, Total T-3 Fpia CalibratorsCDP · Traditional | 01/24/1996SE |
| K954839 | Aspartate Aminotransferase Procedure No.. 58-UVCIT · Traditional | 01/05/1996SE |
| K951584 | Alkaline Phosphatase (Alp/Amp) Procedure No. 247CJE · Traditional | 08/11/1995SE |
| K933934 | GLUCOSE-6-PHOSPHATE Dehydrogenase Deficiency Screening Test Kit No. 202-AJBF · Traditional | 06/29/1995SE |
| K945908 | Glucose (HK) Reagent (Procedure NO.16)CFR · Traditional | 05/08/1995SE |
| K950028 | Primidone Fpia Reagent Set and CalibratorsLFT · Traditional | 03/21/1995SE |
| K942908 | Igm RF EiaDHR · Traditional | 01/20/1995SE |
| K943291 | Anti Ds-DnaLLL · Traditional | 12/02/1994SE |
| K943550 | Gentamicin Fpia Reagent Set and CalibratorsLCQ · Traditional | 11/17/1994SE |
| K944371 | Tobramycin Fpia Reagent Set and CalibratorLFW · Traditional | 11/10/1994SE |
| K944063 | Fluorescence Polarization Immunoassay CarbamazepineLGI · Traditional | 11/10/1994SE |
| K943866 | Valproic Acid Fpia Reagent Set and CalibratorsLEG · Traditional | 11/10/1994SE |
| K943313 | Phenytoin Fpia Reagent Set and CalibratorsLGR · Traditional | 10/27/1994SE |
| K935984 | Glutamyl-Transferase, Procedure No. 419JQB · Traditional | 07/20/1994SE |
| K940840 | Act Control SetJPA · Traditional | 07/19/1994SE |
| K942192 | Theophylline Fpia Reagent Set and CalibratorsLER · Traditional | 07/13/1994SE |
| K940569 | Digoxin Fpia Reagent Set and Calibrator SetKXT · Traditional | 07/13/1994SE |
| K932606 | Apolipoprotien A-1 (Apo A-1)JHN · Traditional | 06/02/1994SE |
| K932603 | Apolipoprotien B (Apo B)JHN · Traditional | 06/02/1994SE |
| K941085 | Lipase-Ps Assay Procedure No. 805CHI · Traditional | 05/17/1994SE |
| K935308 | Accucolor(Tm) Antithrombin III Chromogenic AssayJBQ · Traditional | 05/17/1994SE |
| K935057 | Factor Viii Deficient PlasmaGJT · Traditional | 03/15/1994SE |
| K935058 | FactorGJT · Traditional | 03/07/1994SE |
| K935056 | Factor Vii Deficient PlasmaGJT · Traditional | 03/07/1994SE |
| K935054 | Factor X Deficient PlasmaGJT · Traditional | 03/07/1994SE |
| K933425 | Ammonia/Ethanol Controls, High/Low, Cat.# A7937/7812DKC · Traditional | 11/16/1993SE |
| K932517 | Iron/Uibc ReagentJMO · Traditional | 11/09/1993SE |
| K932980 | Total T4 Fpia Reagent Set/Calibrator #T-1039,T-116CDX · Traditional | 10/18/1993SE |
| K932067 | Ethanol Controls, Urine, Levels 1,II, and IIIDKC · Traditional | 06/16/1993SE |
| K930212 | Thromboplatin-M with CalciumGJS · Traditional | 05/11/1993SE |
| K915462 | Fibrinogen ControlGIL · Traditional | 03/04/1992SE |
| K915380 | Microprotein-PrCEK · Traditional | 02/18/1992SE |
| K915465 | Digitoxin Fpia Reagent SetLFM · Traditional | 01/27/1992SE |
| K915463 | Activated Partial Thromboplastin TimeGGW · Traditional | 01/23/1992SE |
| K915464 | Digitoxin Fpia Calibrator SetDLJ · Traditional | 01/15/1992SE |
| K914777 | Sigma Procedure No. 333-UVDML · Traditional | 12/27/1991SE |
| K913061 | Fibrinogen Determination KitGIS · Traditional | 10/09/1991SE |
| K913858 | Amylase Reagent (Procedure 577)JFJ · Traditional | 09/11/1991SE |
| K912061 | Heparin AdsorbentJPA · Traditional | 07/24/1991SE |
| K910741 | Heparin Controls, High and LowKFF · Traditional | 04/29/1991SE |
| K910255 | Flow Cytometry Fitc/Pe Compensation KitJIW · Traditional | 04/03/1991SE |
| K897147 | Sigma Procedure No. 735KHP · Traditional | 04/03/1990SE |
| K894204 | Calcium (Arsenazo III) ReagentCJY · Traditional | 10/04/1989SE |
| K894063 | Triglyceride (Gpo) Trinder ReagentJGY · Traditional | 09/07/1989SE |
| K884184 | Sigma Procedure No. 465 for Deter. of FructosamineLCP · Traditional | 03/28/1989SE |
| K890674 | Accustain(Tm) - Automated Wright Giemsa Stain SetIAF · Traditional | 02/24/1989SE |
| K890673 | Wright-Glemsa StainIAF · Traditional | 02/24/1989SE |
| K890023 | HDL Cholesterol Reagent (PTA/MGCL2)LBR · Traditional | 02/17/1989SE |
| K881112 | Fungi Histology Control SlidesLJG · Traditional | 04/21/1988SE |
| K881109 | Spirochetes Histology Control SlidesLJG · Traditional | 04/21/1988SE |
| K881106 | Acid Fast Bacilli Histology Control SlidesLJG · Traditional | 04/21/1988SE |
| K880038 | For the Deter. of Hemoglobin in Plasma #527KHG · Traditional | 04/21/1988SE |
| K881110 | Legionella Pneumophilla Histology Control SlidesLJG · Traditional | 04/12/1988SE |
| K881108 | Pneumocystis Carinii Histology Control SlidesLJG · Traditional | 04/12/1988SE |
| K881111 | Intracellular/Extracellular Iron Histology ControlLJG · Traditional | 03/30/1988SE |
| K881107 | Intracellular Amyloid Histology Control SlidesLJG · Traditional | 03/30/1988SE |
| K880268 | CO2 ReagentKHS · Traditional | 03/15/1988SE |
| K880039 | Ammonia Controls Low and High #A 5565 & a 6665JJX · Traditional | 02/24/1988SE |
| K875310 | Reticulocyte StainKFC · Traditional | 02/09/1988SE |
| K874115 | No. 1000-H for Immunofluorometric Deter. of (Ana)LKJ · Traditional | 11/04/1987SE |
| K873342 | Bile Acids ControlsJJX · Traditional | 10/20/1987SE |
| K873365 | Creatinine ReagentCGX · Traditional | 10/02/1987SE |
| K872296 | Bile Acids ReagentKWW · Traditional | 08/26/1987SE |
| K872451 | Bile Acids CalibratorJIT · Traditional | 08/21/1987SE |
| K872197 | Procedure No. 552/553 Bilirubin, Total and DirectCIG · Traditional | 08/13/1987SE |
| K872295 | Cholesterol ReagentCHH · Traditional | 07/16/1987SE |
| K872347 | Digoxin Fpia ControlsLAS · Traditional | 07/07/1987SE |
| K871567 | Phenytoin Fpia ControlsLAS · Traditional | 07/01/1987SE |
| K871152 | Sigma's Calcium Procedure No. 587CIC · Traditional | 06/12/1987SE |
| K871423 | Phenytoin Fpia CalibratorsDLJ · Traditional | 06/11/1987SE |
| K871394 | Theophylline Fpia CalibratorsDLJ · Traditional | 06/01/1987SE |
| K871545 | New Fuchsin SolutionIDF · Traditional | 04/29/1987SE |
| K871544 | Methyl Green SolutionHZA · Traditional | 04/29/1987SE |
| K870951 | Digoxin Fpia Reagent SetKXT · Traditional | 04/01/1987SE |
| K870953 | Phenytoin Fpia Reagent SetDIP · Traditional | 03/31/1987SE |
| K870952 | Theophylline Fpia Reagent SetKLS · Traditional | 03/31/1987SE |
| K870012 | Triglyceride (Gpo-Trinder) ReagentCDT · Traditional | 02/20/1987SE |
| K864713 | Chloride ReagentCHJ · Traditional | 12/31/1986SE |
| K864531 | Tissue Gram StainICF · Traditional | 12/22/1986SE |
| K863751 | Multi-Analyte Lin-TrolJJY · Traditional | 11/24/1986SE |
| K864033 | Rapid Acid Fast StainKJY · Traditional | 11/13/1986SE |
| K864074 | Elastic StainIAC · Traditional | 10/29/1986SE |
| K863851 | Acid Phosphatase (Acp) ReagentCKB · Traditional | 10/16/1986SE |
| K863226 | Albumin (BCP)CJW · Traditional | 09/17/1986SE |
| K863203 | Cholinesterase (BTC) ReagentDIH · Traditional | 09/17/1986SE |
| K863202 | Cholinesterase (PTC) ReagentDIH · Traditional | 09/16/1986SE |
| K862905 | Alp (Opt) ReagentCJE · Traditional | 08/29/1986SE |
| K863196 | Bun (Rate) ReagentCDQ · Traditional | 08/26/1986SE |
| K861314 | Cholesterol CalibratorsJIT · Traditional | 07/01/1986SE |
| K861467 | Albumin (BCG) ReagentCIX · Traditional | 05/23/1986SE |
| K860138 | No. 615 Determination of Ceruloplasmin in SerumDDB · Traditional | 03/28/1986SE |
| K860453 | Ace Controls, Normal & Elevated, No. A6040 & A7040JJX · Traditional | 02/19/1986SE |
| K854245 | Sigma Angiotensin Converting Enzyme 305-UVKQN · Traditional | 01/22/1986SE |
| K854501 | Ck(Optimized) ReagentCGS · Traditional | 12/04/1985SE |
| K854503 | Ast(Optimized) ReagentCIT · Traditional | 11/25/1985SE |
| K854502 | Alt(Optimized) ReagentCKA · Traditional | 11/25/1985SE |
| K853681 | Sigma 610 for Protein in Urine & CSFCEK · Traditional | 10/28/1985SE |
| K853896 | Gram Stain KitJTS · Traditional | 10/22/1985SE |
| K853357 | Uric Acid ReagentKNK · Traditional | 08/19/1985SE |
| K852131 | Bun(Endpoint) ReagentCDQ · Traditional | 06/10/1985SE |
| K852130 | Glucose(Trinder) ReagentCGA · Traditional | 06/10/1985SE |
| K850923 | Bun (Rate) ReagentCDQ · Traditional | 03/20/1985SE |
| K850319 | Y-Glutamyltransferase(Y-Gt) ReagentJQB · Traditional | 02/12/1985SE |
| K844468 | Triglyceride CalibratorJIT · Traditional | 12/11/1984SE |
| K844032 | Triglyceride ReagentCDT · Traditional | 11/09/1984SE |
| K841918 | Sigma Proced. 245 Alkaline PhosphataseCJE · Traditional | 06/14/1984SE |
| K841917 | Sigms Proced. 228 UV Lactate DehydroCFJ · Traditional | 06/14/1984SE |