Test, Qualitative And Quantitative Factor Deficiency
FDA product code GGP · Class II (moderate risk) · 21 CFR 864.7290 · Hematology
190510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Instrumentation Laboratory CO 28
- American Bioproducts Co. 22
- Helena Laboratories 17
- Sigma Chemical Co. 9
- American Dade 9
- Biopool AB 9
- Precision Biologic 7
- Baxter Healthcare Corp 6
- Behring Diagnostics, Inc. 5
- Universal Reagents, Inc. 5
- Medical Diagnostic Technologies, Inc. 5
- Ortho Diagnostic Systems, Inc. 4
- American Diagnostica, Inc. 4
- Ramco Laboratories, Inc. 4
- Reaads Medical Products, Inc. 3
- Diatech, Inc. 3
- Kabivitrum, Inc. 3
- Shield Diagnostics, Ltd. 3
- Dade Behring, Inc. 3
- Siemens Healthcare Diagnostics Products GmbH 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIIIGGP · Traditional | Precision Biologic, Inc. | 08/25/2025SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | Instrumentation Laboratory Company | 12/13/2023SE |
| K220728 | vWF AgGGP · Traditional | Siemens Healthcare Diagnostics Products GmbH | 06/02/2023SE |
| K214002 | CRYOcheck Chromogenic Factor IXGGP · Traditional | Precision Biologic, Inc. | 12/23/2022SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | Instrumentation Laboratory CO | 12/09/2022SE |
| K200033 | HemosIL von Willebrand Factor AntigenGGP · Special | Instrumentation Laboratory CO | 08/19/2020SE |
| K193204 | Cryocheck Chromogenic Factor VIIIGGP · Traditional | Precision Biologic | 07/17/2020SE |
| K183440 | CRYOcheck FVIII Inhibitor KitGGP · Traditional | Precision Biologic, Inc. | 03/12/2019SE |
| K181525 | INNOVANCE Free PS AgGGP · Traditional | Siemens Healthcare Diagnostics Products GmbH | 09/07/2018SE |
| K133005 | Hemosil Von Willebrand Activity AssayGGP · Special | Instrumentation Laboratory CO | 03/13/2014SE |
| K102164 | Hemosil Protein S Activity AssayGGP · Traditional | Instrumentation Laboratory CO | 03/17/2011SE |
| K092170 | Sta Liatest Free PSGGP · Special | Diagnostica Stago, Inc. | 12/22/2009SE |
| K082631 | Thrombo Tek Pse, Model 90-480GGP · Traditional | R2 Diagnostics, Inc. | 12/17/2008SE |
| K082205 | Factor Viii Antibody ScreenGGP · Traditional | Genetic Testing Institute | 11/20/2008SE |
| K063323 | Spectrolyse PAI-1, Model 101201GGP · Traditional | American Diagnostica, Inc. | 08/15/2007SE |
| K070635 | Hemosil ProclotGGP · Special | Instrumentation Laboratory CO | 03/29/2007SE |
| K062530 | Triage Protein C TestGGP · Traditional | Biosite Incorporated | 01/29/2007SE |
| K062430 | Hemosil Protein CGGP · Special | Instrumentation Laboratory CO | 09/01/2006SE |
| K052825 | Visulize Factor Viii Antigen Kit, Model Fviii-AgGGP · Traditional | Affinity Biologicals, Inc. | 01/20/2006SE |
| K053499 | Hemosil ProsGGP · Special | Instrumentation Laboratory CO | 01/13/2006SE |
| K050365 | Biophen Protein C5, C2.5, Models 221205, 221202GGP · Traditional | Hyphen Biomed | 12/27/2005SE |
| K050448 | Chromopep PC, Chromopep at, Models 2.5 and 5GGP · Traditional | Horiba Abx | 09/23/2005SE |
| K051054 | Visulize Factor Ix Antigen KitGGP · Traditional | Affinity Biologicals, Inc. | 06/29/2005SE |
| K043571 | Cryocheck Clot SGGP · Traditional | Precision Biologic, Inc. | 03/18/2005SE |
| K042576 | Coatest SP FviiiGGP · Traditional | Instrumentation Laboratory CO | 12/02/2004SE |
| K040987 | Cryocheck Clot CGGP · Traditional | Precision Biologic, Inc. | 06/18/2004SE |
| K040843 | Hemosil Von Willebrand ActivityGGP · Traditional | Instrumentation Laboratory CO | 04/30/2004SE |
| K032139 | Reaads Von Willebrand Factor Activity Test Kit, Model 10826GGP · Traditional | Corgenix, Inc. | 04/05/2004SE |
| K033631 | Modification to Coatest Factor ViiiGGP · Special | Instrumentation Laboratory CO | 12/15/2003SE |
| K023990 | Chromocheck Protein C 25; Chromocheck Protein C 50GGP · Traditional | Precision Biologic | 03/19/2003SE |
| K022290 | Protein S AcGGP · Traditional | Dade Behring, Inc. | 08/27/2002SE |
| K013492 | Imubind Tpa Elisa, Model 860GGP · Traditional | American Diagnostica, Inc. | 03/13/2002SE |
| K013168 | Imubind Plasma PAI-1 Elisa,Model 822GGP · Traditional | American Diagnostica, Inc. | 03/07/2002SE |
| K012386 | Acticlot Protein S, Model 843LGGP · Traditional | American Diagnostica, Inc. | 09/14/2001SE |
| K011424 | Il Test ProsGGP · Traditional | Instrumentation Laboratory CO | 06/25/2001SE |
| K010963 | Sta-Liatest Free Protein S Test KitGGP · Traditional | Diagnostica Stago, Inc. | 06/06/2001SE |
| K010379 | Il Test Free Protein SGGP · Traditional | Instrumentation Laboratory CO | 04/13/2001SE |
| K002467 | Coaliza Protein S-FreeGGP · Traditional | Instrumentation Laboratory CO | 10/13/2000SE |
| K002350 | Refacto Laboratory StandardGGP · Traditional | The Genetics Institute | 10/05/2000SE |
| K002541 | Protein C ReagentGGP · Traditional | Dade Behring, Inc. | 09/26/2000SE |
| K000649 | Sysmex Automated Coagulation Analyzer, Model CA-1500GGP · Traditional | Dade Behring, Inc. | 04/25/2000SE |
| K000398 | Shield Von Willebrand Factor Activity Elisa, Model FVWF 200GGP · Traditional | Shield Diagnostics, Ltd. | 04/17/2000SE |
| K993553 | Gti-Fviii Inhibitor AssayGGP · Traditional | Genetic Testing Institute | 02/01/2000SE |
| K992704 | Il Test Von Willebrand FactorGGP · Traditional | Instrumentation Laboratory CO | 11/01/1999SE |
| K983898 | Bioclot Apc SensitivityGGP · Traditional | Biopool Intl., Inc. | 01/06/1999SE |
| K983914 | Reaads Monoclonal Free Protein S Antigen Test KitGGP · Traditional | Corgenix, Inc. | 12/22/1998SE |
| K983107 | VfeGGP · Traditional | Ramco Laboratories, Inc. | 10/22/1998SE |
| K981817 | Coamatic Plasmin InhibitorGGP · Traditional | Instrumentation Laboratory CO | 09/28/1998SE |
| K981696 | Il Test Plasmin InhibitorGGP · Traditional | Instrumentation Laboratory CO | 08/27/1998SE |
| K980885 | Shield Activated Factor Xii (Elisa) AssayGGP · Traditional | Shield Diagnostics, Ltd. | 08/21/1998SE |
| K981200 | Il Test PlasminogenGGP · Traditional | Instrumentation Laboratory CO | 05/26/1998SE |
| K974711 | Coamatic PlasminogenGGP · Traditional | Instrumentation Laboratory CO | 05/01/1998SE |
| K980875 | Il Test Protein CGGP · Traditional | Instrumentation Laboratory CO | 04/21/1998SE |
| K981038 | Coamatic Factor ViiiGGP · Traditional | Instrumentation Laboratory CO | 04/16/1998SE |
| K971985 | N-Assay Tia Plasminogen Test KitGGP · Traditional | Crestat Diagnostics, Inc. | 10/20/1997SE |
| K972342 | Reaads Protein C Antigen Test KitGGP · Traditional | Reaads Medical Products, Inc. | 10/06/1997SE |
| K973143 | Universal Reagent Factor Xii (Twelve) Deficient PlasmaGGP · Traditional | Universal Reagents, Inc. | 09/25/1997SE |
| K971519 | Asserachrom Tpa Test KitGGP · Traditional | American Bioproducts Co. | 08/19/1997SE |
| K972482 | Reaads Protein S Antigen Test KitGGP · Traditional | Reaads Medical Products, Inc. | 08/13/1997SE |
| K972005 | Reaads Von Willebrand Factor Antigen Test KitGGP · Traditional | Reaads Medical Products, Inc. | 08/13/1997SE |
| K972116 | Von Willebrand ReagentGGP · Traditional | Behring Diagnostics, Inc. | 07/25/1997SE |
| K972288 | Factor Deficient Plasmas - Factor Ix (9)GGP · Traditional | Universal Reagents, Inc. | 07/14/1997SE |
| K951640 | Human Protein S Rid Test KitGGP · Traditional | The Binding Site, Ltd. | 04/21/1997SE |
| K964459 | Universal Reagent Factor X Deficient PlasmaGGP · Traditional | Universal Reagents, Inc. | 12/18/1996SE |
| K964270 | Universal Reagent Factor V Deficient PlasmaGGP · Traditional | Universal Reagents, Inc. | 12/18/1996SE |
| K962968 | Proc Apc Assay, Proc Control PlasmaGGP · Traditional | Behring Diagnostics, Inc. | 12/13/1996SE |
| K963106 | Chromolize PAI-1 KitGGP · Traditional | Medical Diagnostic Technologies, Inc. | 11/18/1996SE |
| K962825 | Shield Von Willebrand Factor Activity (Elisa) AssayGGP · Traditional | Shield Diagnostics, Ltd. | 11/15/1996SE |
| K961929 | Factor Deficient PlasmaGGP · Traditional | Universal Reagents, Inc. | 10/10/1996SE |
| K962489 | Chromolize Tpa Assay KitGGP · Traditional | Medical Diagnostic Technologies, Inc. | 07/31/1996SE |
| K960438 | Tintelize PAI-1 KitGGP · Traditional | Medical Diagnostic Technologies, Inc. | 06/05/1996SE |
| K955738 | Bioclot Protein SGGP · Traditional | Medical Diagnostic Technologies, Inc. | 02/29/1996SE |
| K952126 | Aalto Scientific Liquid Cerebrospinal Fluid Controls Levels I and IIGGP · Traditional | Aalto Scientific, Ltd. | 02/29/1996SE |
| K952668 | Chrom Z-F:Viii, Cat. No. 5241GGP · Traditional | Helena Laboratories | 02/09/1996SE |
| K952666 | Chrom Z-Protein C, Cat. No. 5243GGP · Traditional | Helena Laboratories | 01/30/1996SE |
| K952669 | Chrom Z-Plasminogen, Cat. No. 5244GGP · Traditional | Helena Laboratories | 12/07/1995SE |
| K954040 | Asserachrom Total Protein S KitGGP · Traditional | American Bioproducts Co. | 11/13/1995SE |
| K954017 | Asserachrom Free Protein S KitGGP · Traditional | American Bioproducts Co. | 11/13/1995SE |
| K943225 | Coamatic Factor ViiiGGP · Traditional | Pharmacia Hepar, Inc. | 11/06/1995SE |
| K941752 | Spectrolyse Antiplasmin KitGGP · Traditional | Biopool AB | 09/25/1995SESK |
| K942087 | Biopool VWF Eld Kit and VWF Eld Bulk PlatesGGP · Traditional | Biopool AB | 07/13/1995SE |
| K950015 | Human Protein C Rid Test KitGGP · Traditional | Jay H. Geller | 03/06/1995SE |
| K924425 | Protein C Reagent, CoagulometricGGP · Traditional | Behring Diagnostics, Inc. | 01/24/1995SE |
| K945414 | Ristocetin Cofactor Assay KitGGP · Traditional | Chrono-Log Corp. | 01/11/1995SE |
| K934210 | Hemolab Protein C Chromogenic AssayGGP · Traditional | Biomerieux Vitek, Inc. | 12/22/1994SE |
| K934314 | Tintelizer(R) TpaGGP · Traditional | Biopool AB | 02/23/1994SE |
| K925617 | Mda Protein AssayGGP · Traditional | Organon Teknika Corp. | 01/27/1994SE |
| K934584 | Spectrolyse Factor Vii:CGGP · Traditional | Meditech, Inc. | 12/06/1993SE |
| K931906 | New Stachrom Protein C Test KitGGP · Traditional | American Bioproducts Co. | 11/05/1993SE |
| K930235 | Hemochron/Factor Vi Whole Blood Factor Viii AssayGGP · Traditional | Technidyne Corp. | 09/02/1993SE |
| K930327 | Il Test(Tm) Protein SGGP · Traditional | Instrumentation Laboratory CO | 04/12/1993SE |
| K924884 | Il Test(Tm) Pro-ChromGGP · Traditional | Instrumentation Laboratory CO | 01/14/1993SE |
| K922201 | Coamate Protein C Chromogenic AssayGGP · Traditional | Chromogenix AB | 12/07/1992SE |
| K922782 | Spectrolyse/Pl Pai KitGGP · Traditional | Biopool AB | 10/09/1992SE |
| K921449 | New Stachrom AntiplasminGGP · Traditional | American Bioproducts Co. | 09/23/1992SE |
| K920012 | Il Test(Tm) ALPHA-2-ANTIPLASMIN Assay SystemGGP · Traditional | Instrumentation Laboratory CO | 08/12/1992SE |
| K920981 | Ristocetin Cofactor Assay/Von Willebrand Fact AssaGGP · Traditional | Medical Diagnostic Technologies, Inc. | 04/17/1992SE |
| K914818 | Dade(R) Alpha 2 ANTIPLASMIN(2 2-AP) Chromo AssayGGP · Traditional | Baxter Diagnostics, Inc. | 01/15/1992SE |
| K915163 | Protein S Eid Kit and Protein S Eid Bulk PlatesGGP · Traditional | Biopool AB | 01/06/1992SE |
| K914307 | Spectrolyse Protein C KitGGP · Traditional | Biopool AB | 12/09/1991SE |
| K912711 | Il Test Proclot Assay StystemGGP · Traditional | Instrumentation Laboratory CO | 10/09/1991SE |
| K913424 | Staclot(R) Protein S Test KitGGP · Traditional | American Bioproducts Co. | 10/08/1991SE |
| K912468 | Liatest Protein S KitGGP · Traditional | American Bioproducts Co. | 10/02/1991SE |
| K912025 | Spectrolyse Plasminogen SK KitGGP · Traditional | Biopool AB | 08/22/1991SE |
| K903468 | Dade Protein C Clotting AssayGGP · Traditional | Baxter Healthcare Corp | 02/26/1991SE |
| K904247 | Free Protein S Reagent Cat. No. 5363GGP · Traditional | Helena Laboratories | 01/18/1991SE |
| K902566 | Biopool Protein C Eid Kit and Bulk PlatesGGP · Traditional | Biopool AB | 08/09/1990SE |
| K902528 | Bioclot C KitGGP · Traditional | Biopool AB | 08/09/1990SE |
| K900399 | Orthokrome* PlasminogenGGP · Traditional | Ortho Diagnostic Systems, Inc. | 03/15/1990SE |
| K900398 | Orthokrome* Protein CGGP · Traditional | Ortho Diagnostic Systems, Inc. | 03/15/1990SE |
| K900397 | Orthokrome* AntiplasminGGP · Traditional | Ortho Diagnostic Systems, Inc. | 03/15/1990SE |
| K900395 | Orthokrome* Factor ViiiGGP · Traditional | Ortho Diagnostic Systems, Inc. | 03/15/1990SE |
| K896174 | Protein S Antigen Rocket Eid Kit, Cat. No. 5359GGP · Traditional | Helena Laboratories | 03/15/1990SE |
| K897136 | Protein C Antigen Rocket Eid Method No. 5357GGP · Traditional | Helena Laboratories | 02/05/1990SE |
| K892859 | The Stago Viii Deficient Plasma KitGGP · Traditional | American Bioproducts Co. | 06/23/1989SE |
| K890634 | Berichrom Protein C KitGGP · Traditional | Behring Diagnostics, Inc. | 04/21/1989SE |
| K884797 | Berichrom ALPHA-2-ANTIPLASMINGGP · Traditional | Behring Diagnostics, Inc. | 04/21/1989SE |
| K884941 | Acticlot C KitGGP · Traditional | American Diagnostic Corp. | 03/13/1989SE |
| K884940 | Rellplate C Kit, Rellplate C Bulk PlatesGGP · Traditional | American Diagnostic Corp. | 03/13/1989SE |
| K890409 | Dade(R) Plasminogen Chromogenic AssayGGP · Traditional | Baxter Healthcare Corp | 02/27/1989SE |
| K884881 | Dade Protein C Chromogenic AssayGGP · Traditional | Baxter Healthcare Corp | 02/02/1989SE |
| K884551 | Dade Factor Ix Chromogenic AssayGGP · Traditional | Baxter Healthcare Corp | 12/30/1988SE |
| K884544 | Dade Factor Viii Chromogenic AssayGGP · Traditional | Baxter Healthcare Corp | 12/30/1988SE |
| K884058 | Coatest Protein CGGP · Traditional | Kabivitrum, Inc. | 12/13/1988SE |
| K882603 | Stachrom Antiplasmin ControlGGP · Traditional | American Bioproducts Co. | 09/02/1988SE |
| K882602 | Stachrom Antiplasmin Test KitGGP · Traditional | American Bioproducts Co. | 09/02/1988SE |
| K881037 | Spectrolyse/FibrinGGP · Traditional | Cytrx Biopool, Ltd. | 07/01/1988SE |
| K874940 | Calibration Reference PlasmaGGP · Traditional | Baxter Healthcare Corp | 02/09/1988SE |
| K874097 | Stachrom Viii:C Test KitGGP · Traditional | American Bioproducts Co. | 12/03/1987SE |
| K872941 | Spectro CGGP · Traditional | Ramco Laboratories, Inc. | 09/04/1987SE |
| K872479 | Asserachrom Protein S Test KitGGP · Traditional | American Bioproducts Co. | 08/21/1987SE |
| K871039 | Stachrom Protein C Test KitGGP · Traditional | American Bioproducts Co. | 05/21/1987SE |
| K870917 | Protein S Control PlasmaGGP · Traditional | American Bioproducts Co. | 04/23/1987SE |
| K864701 | VWF ImmunoblotGGP · Traditional | Ramco Laboratories, Inc. | 03/30/1987SE |
| K870354 | Immunoadsorbed Factor V Deficient Plasma (Human)GGP · Traditional | American Dade | 02/10/1987SE |
| K870353 | Immunoadsorbed Factor X Deficient Plasma (Human)GGP · Traditional | American Dade | 02/10/1987SE |
| K864480 | Il Test 84668-15, Factor Viii Control PlasmaGGP · Traditional | Instrumentation Laboratory CO | 01/21/1987SE |
| K864497 | Coagulation Extrinsic Deficient PlasmasGGP · Traditional | Instrumentation Laboratory CO | 01/05/1987SE |
| K864481 | Coagulation Intrinsic Deficient PlasmasGGP · Traditional | Instrumentation Laboratory CO | 01/05/1987SE |
| K861475 | Assera-Plate Protein C KitGGP · Traditional | American Bioproducts Co. | 06/25/1986SE |
| K861417 | Assera-Plate VWF KitGGP · Traditional | American Bioproducts Co. | 06/25/1986SE |
| K861079 | Staclot Protein C Test KitGGP · Traditional | American Bioproducts Co. | 06/19/1986SE |
| K861049 | High Molecular Weight Kininogen(Hmwk) Def PlasmaGGP · Traditional | Sigma Chemical Co. | 05/29/1986SE |
| K861048 | Prekallikrein Deficient Plasma, Cat. No. B 6765GGP · Traditional | Sigma Chemical Co. | 05/29/1986SE |
| K861217 | Vwf-Ix:Ag Control PlasmaGGP · Traditional | American Bioproducts Co. | 05/20/1986SE |
| K861216 | Protein C Control PlasmaGGP · Traditional | American Bioproducts Co. | 05/16/1986SE |
| K861159 | Spectro VWFGGP · Traditional | Ramco Laboratories, Inc. | 05/01/1986SE |
| K860371 | Asserachrom VWF KitGGP · Traditional | American Bioproducts Co. | 04/04/1986SE |
| K854312 | Asserachrom Ix:AgGGP · Traditional | American Bioproducts Co. | 02/04/1986SE |
| K854014 | Assera Plate Ix:Ag KitGGP · Traditional | American Bioproducts Co. | 01/03/1986SE |
| K853462 | Coagulation Factor Viii Deficient Substrate PlasmaGGP · Traditional | American Dade | 08/29/1985SE |
| K853461 | Coagulation Factor Ix Deficient Substrate PlasmaGGP · Traditional | American Dade | 08/29/1985SE |
| K843451 | Factor Xii Deficient Plasma B12DGGP · Traditional | Sigma Chemical Co. | 11/19/1984SE |
| K843438 | Factor Xi Deficient Plasma B11DGGP · Traditional | Sigma Chemical Co. | 11/19/1984SE |
| K843310 | Factor X Deficient Plasma, Blod HumanGGP · Traditional | Sigma Chemical Co. | 11/19/1984SE |
| K843215 | Factor Ix Deficient Plasma, B9D -GGP · Traditional | Sigma Chemical Co. | 11/19/1984SE |
| K842617 | Vonwillebrand Factor Antigen Semi-QuantGGP · Traditional | American Dade | 10/01/1984SE |
| K841957 | Bovine Factor Xa-Human Factor XaGGP · Traditional | Haemachem, Inc. | 07/19/1984SE |
| K841708 | Meloy Immunostat Monoclonal Factor ViiiGGP · Traditional | Meloy Laboratories, Inc. | 07/19/1984SE |
| K841461 | Coagulation Control Plasma Level 1/2/3GGP · Traditional | Diatech, Inc. | 05/02/1984SE |
| K840928 | Factor Deficient Substrate Plasma ViiiGGP · Traditional | Diatech, Inc. | 04/30/1984SE |
| K840927 | Factor Deficient Substrate Plasma IIGGP · Traditional | Diatech, Inc. | 04/30/1984SE |
| K841364 | Coagulation Factor V Deficient SubstrGGP · Traditional | American Dade | 04/25/1984SE |
| K840329 | Ristocetin Cofactor AssayGGP · Traditional | Helena Laboratories | 04/05/1984SE |
| K840114 | Coagulation Factor Deficient PlasmaGGP · Traditional | Medical Specialties Laboratories | 02/04/1984SE |
| K834051 | Protopath Factor Viii AssayGGP · Traditional | American Dade | 02/04/1984SE |
| K834050 | Protopath Factor Ix AssayGGP · Traditional | American Dade | 02/04/1984SE |
| K833892 | Coatest Factor ViiiGGP · Traditional | Kabivitrum, Inc. | 01/30/1984SE |
| K834031 | Factor II Deficient Substrate PlasmaGGP · Traditional | Helena Laboratories | 12/16/1983SE |
| K832372 | Diacrom * Factor X Kit HA31GGP · Traditional | Wellcome Diagnostics | 09/29/1983SE |
| K832114 | Coatest Factor XGGP · Traditional | Kabivitrum, Inc. | 08/26/1983SE |
| K823453 | Von Willebrand Factor AssayGGP · Traditional | General Diagnostics | 01/21/1983SE |
| K823267 | Factor Viii Related Antigen Rocket EidGGP · Traditional | Helena Laboratories | 12/28/1982SE |
| K821963 | EIA-F8 Enzymeimmunoassay Kit for Quant.GGP · Traditional | Intl. Immunoassay Laboratories, Inc. | 07/27/1982SE |
| K820085 | Dade Factor Assay Reference PlasmaGGP · Traditional | American Dade | 02/23/1982SE |
| K812975 | Lancer Coagent Human Vactor Viii PlasmaGGP · Traditional | Sherwood Medical Co. | 11/16/1981SE |
| K812974 | Lancer Coagent Human Factor 1X PlasmaGGP · Traditional | Sherwood Medical Co. | 11/16/1981SE |
| K812431 | Factor Viii Deficient Plasma #B8DGGP · Traditional | Sigma Chemical Co. | 09/23/1981SE |
| K802356 | Von Willebrand Factor AssayGGP · Traditional | Bio/Data Corp. | 12/01/1980SE |
| K792656 | Helena Factor Xii DeficientGGP · Traditional | Helena Laboratories | 01/24/1980SE |
| K792511 | Helena Factor Vii Deficient Sub. PlasmaGGP · Traditional | Helena Laboratories | 12/31/1979SE |
| K792508 | Helena Factor X Deficient SubstrateGGP · Traditional | Helena Laboratories | 12/31/1979SE |
| K792507 | Helena Factor V Deficient SubstrateGGP · Traditional | Helena Laboratories | 12/31/1979SE |
| K792476 | Helena Factor Xi Deficient SubstrateGGP · Traditional | Helena Laboratories | 12/31/1979SE |
| K792475 | Helena Factor Ix Deficient SubstrateGGP · Traditional | Helena Laboratories | 12/31/1979SE |
| K792336 | Helena Factor II Deficient Sub. PlasmaGGP · Traditional | Helena Laboratories | 12/27/1979SE |
| K792335 | Helena Factor Viii Deficient Sub. PlasmaGGP · Traditional | Helena Laboratories | 12/04/1979SE |
| K791794 | Factor Vii Deficient PlasmaGGP · Traditional | Sigma Chemical Co. | 10/01/1979SE |
| K790423 | Factor V DeficientGGP · Traditional | Sigma Chemical Co. | 04/04/1979SE |
| K761058 | QUAN-8 Mult-Comp Factor Viii Assay KitGGP · Traditional | Bio/Data Corp. | 02/07/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3047-2026 Class II | STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074…A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified | Diagnostica Stago, Inc. | 07/29/2026Open, Classified |
| Z-1491-2026 Class II | Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S…The potential of out-of-range results and an underestimation of the free protein S level in normal patient… | Diagnostica Stago, Inc. | 02/04/2026Open, Classified |
| Z-1227-2023 Class II | BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity…New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5… | Aniara Diagnostica LLC | 02/01/2023Open, Classified |
| Z-1699-2020 Class II | STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted…A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments… | Diagnostica Stago, Inc. | 03/04/2020Terminated |
| Z-0106-2019 Class II | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free…Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S… | Helena Laboratories, Inc. | 04/04/2017Terminated |
| Z-0736-2016 Class II | HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit…This Lot is not meeting labeled on-board instrument stability claims of 5 days. | Instrumentation Laboratory Co. | 12/18/2015Terminated |
| Z-0468-2016 Class II | Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN)…Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for… | Siemens Healthcare Diagnostics, Inc. | 11/19/2015Terminated |
| Z-0463-2013 Class II | Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative…Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing… | Sekisui Diagnostics Llc | 10/24/2012Terminated |
| Z-2431-2012 Class II | Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of…SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This… | Sekisui Diagnostics Llc | 08/28/2012Terminated |
| Z-1519-2012 | Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part…Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay. | Instrumentation Laboratory Co. | 04/11/2012Terminated |
| Z-1426-2010 | REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked…Unacceptable microwell to microwell variation in the section of the plate that is typically used for the… | American Diagnostica, Inc. | 03/05/2010Terminated |
| Z-1072-2007 | STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the…Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and… | Diagnostica Stago, Inc. | 05/08/2007Terminated |
| Z-0853-2007 | STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay…A dose-hook effect is observed starting from VWF:AG levels of 300%, while the package insert indicates that… | Diagnostica Stago, Inc. | 03/13/2007Terminated |