Product code GGP
- Device name
- Test, Qualitative And Quantitative Factor Deficiency
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7290
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | 2025-08-25 |
| K230852 | HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company | 2023-12-13 |
| K220728 | vWF Ag | Siemens Healthcare Diagnostics Products GmbH | 2023-06-02 |
| K214002 | CRYOcheck Chromogenic Factor IX | Precision Biologic, Inc. | 2022-12-23 |
| K223402 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | 2022-12-09 |
| K200033 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | 2020-08-19 |
| K193204 | Cryocheck Chromogenic Factor VIII | Precision Biologic | 2020-07-17 |
| K183440 | CRYOcheck FVIII Inhibitor Kit | Precision Biologic, Inc. | 2019-03-12 |
| K181525 | INNOVANCE Free PS Ag | Siemens Healthcare Diagnostics Products GmbH | 2018-09-07 |
| K133005 | HEMOSIL VON WILLEBRAND ACTIVITY ASSAY | Instrumentation Laboratory CO | 2014-03-13 |
| K102164 | HEMOSIL PROTEIN S ACTIVITY ASSAY | Instrumentation Laboratory CO | 2011-03-17 |
| K092170 | STA LIATEST FREE PS | Diagnostica Stago, Inc. | 2009-12-22 |
| K082631 | THROMBO TEK PSE, MODEL 90-480 | R2 Diagnostics, Inc. | 2008-12-17 |
| K082205 | FACTOR VIII ANTIBODY SCREEN | Genetic Testing Institute | 2008-11-20 |
| K063323 | SPECTROLYSE PAI-1, MODEL 101201 | American Diagnostica, Inc. | 2007-08-15 |
| K070635 | HEMOSIL PROCLOT | Instrumentation Laboratory CO | 2007-03-29 |
| K062530 | TRIAGE PROTEIN C TEST | Biosite Incorporated | 2007-01-29 |
| K062430 | HEMOSIL PROTEIN C | Instrumentation Laboratory CO | 2006-09-01 |
| K052825 | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG | Affinity Biologicals, Inc. | 2006-01-20 |
| K053499 | HEMOSIL PROS | Instrumentation Laboratory CO | 2006-01-13 |
| K050365 | BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 | Hyphen Biomed | 2005-12-27 |
| K050448 | CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 | Horiba Abx | 2005-09-23 |
| K051054 | VISULIZE FACTOR IX ANTIGEN KIT | Affinity Biologicals, Inc. | 2005-06-29 |
| K043571 | CRYOCHECK CLOT S | Precision Biologic, Inc. | 2005-03-18 |
| K042576 | COATEST SP FVIII | Instrumentation Laboratory CO | 2004-12-02 |
| K040987 | CRYOCHECK CLOT C | Precision Biologic, Inc. | 2004-06-18 |
| K040843 | HEMOSIL VON WILLEBRAND ACTIVITY | Instrumentation Laboratory CO | 2004-04-30 |
| K032139 | REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 | Corgenix, Inc. | 2004-04-05 |
| K033631 | MODIFICATION TO COATEST FACTOR VIII | Instrumentation Laboratory CO | 2003-12-15 |
| K023990 | CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 | Precision Biologic | 2003-03-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00843876000602 | CRYOcheck Factor VIII Chromogenic | Precision Biologic Inc | 2025-11-25 |
| 00630414320366 | BC von Willebrand Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-09-12 |
| 00843876000565 | CRYOcheck Chromogenic Factor IX | Precision Biologic Inc | 2023-01-06 |
| 00843876000503 | CRYOcheck⢠FVIII Inhibitor Kit | Precision Biologic Inc | 2019-03-25 |
| 10629009020009 | VisuLize Factor FIX Antigen Kit | Affinity Biologicals Inc | 2017-04-28 |
| 10629009010000 | VisuLize Factor FVIII Antigen Kit | Affinity Biologicals Inc | 2017-04-28 |
| M52553570 | Protein C Antigen Rocket Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553730 | Ristocetin Cofactor Abnormal Control Plasma | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553720 | Helena Ristocetin - 10 mg/mL | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553710 | Lyophilized Platelets | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553700 | Ristocetin Cofactor Assay Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553630 | Free Protein S Reagent | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553610 | von Willebrand Factor Antigen Rocket Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553600 | Rocket Stain | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553590 | Protein S Antigen Rocket Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52553560 | Lyophilized Platelets | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551970 | Factor XII Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551960 | Factor XI Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551950 | Factor X Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551940 | Factor IX Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551930 | Factor VIII Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551920 | Factor VII Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551910 | Factor V Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551900 | Factor II Deficient Substrate Plasma | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| 03663537008238 | BIOPHEN Protein C 5 | HYPHEN BIOMED | 2016-08-25 |
| 03663537008221 | BIOPHEN Protein C 2.5 | HYPHEN BIOMED | 2016-08-25 |
| M52552930 | Monoclonal Free Protein S ELISA Kit | HELENA LABORATORIES CORPORATION | 2016-08-22 |
| M52552920 | Protein S ELISA Kit | HELENA LABORATORIES CORPORATION | 2016-08-22 |
| M52552910 | Protein C ELISA Kit | HELENA LABORATORIES CORPORATION | 2016-08-22 |
| M52552900 | von Willebrand Factor Antigen ELISA Kit (96 tests) | HELENA LABORATORIES CORPORATION | 2016-08-22 |