Test, Time, Partial Thromboplastin
FDA product code GGW · Class II (moderate risk) · 21 CFR 864.7925 · Hematology
32510(k) clearances
0PMA approvals
2recalls
Manufacturers
- American Bioproducts Co. 4
- Helena Laboratories 3
- Bio/Data Corp. 3
- R2 Diagnostics, Inc. 2
- American Dade 2
- Instrumentation Laboratory (IL) Co. 1
- Sherwood Medical Co. 1
- Pentapharm , Ltd. 1
- Gradipore , Ltd. 1
- Precision Biologicals, Inc. 1
- Chromogenix AB 1
- Axis-Shield Doc AS 1
- Sigma Diagnostics, Inc. 1
- Biosearch Medical Products, Inc. 1
- E.I. Dupont DE Nemours & Co., Inc. 1
- Diatech, Inc. 1
- Ortho Diagnostic Systems, Inc. 1
- Pacific Hemostasis 1
- General Diagnostics 1
- Electro-Nucleonics Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V)GGW · Special | Instrumentation Laboratory (IL) Co. | 03/20/2026SE |
| K090105 | Lupotek KCTGGW · Traditional | R2 Diagnostics, Inc. | 12/30/2010SE |
| K083729 | Hemoclot Quanti- V-L, Factor V-L Calibrator, Biophen V-L Cal (Undiluted), Biophen Act.…GGW · Traditional | Aniara Diagnostica, LLC | 05/08/2009SE |
| K060284 | Cryocheck Clot ApcrGGW · Traditional | Precision Biologic, Inc. | 05/10/2006SE |
| K042762 | Pefakit Apc-R Factor V LeidenGGW · Traditional | Pentapharm , Ltd. | 12/22/2004SE |
| K033471 | Phospholin Es and Calcium ChlorideGGW · Traditional | R2 Diagnostics, Inc. | 02/04/2004SE |
| K992456 | Gradileiden V TestGGW · Traditional | Gradipore , Ltd. | 12/21/1999SE |
| K982062 | Cryo-Check PNP Platelet Lysate, Model PNP-10GGW · Traditional | Precision Biologicals, Inc. | 01/13/1999SE |
| K963111 | Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SGGW · Traditional | Chromogenix AB | 12/23/1996SE |
| K945940 | Coatest(R) Apc(Tm) ResistanceGGW · Traditional | Axis-Shield Doc AS | 08/07/1995SE |
| K941210 | Ptt-Lt Test KitGGW · Traditional | American Bioproducts Co. | 03/21/1995SESK |
| K924370 | Staclot(R) PNP Test KitGGW · Traditional | American Bioproducts Co. | 08/09/1993SE |
| K921684 | Ptt-La Test KitGGW · Traditional | American Bioproducts Co. | 06/09/1992SE |
| K915463 | Activated Partial Thromboplastin TimeGGW · Traditional | Sigma Diagnostics, Inc. | 01/23/1992SE |
| K902236 | Reads Anti-Cardiolipin Semi-Quantitative Test KitGGW · Traditional | Biosearch Medical Products, Inc. | 08/14/1990SE |
| K873382 | Platelet Extract ReagentGGW · Traditional | Bio/Data Corp. | 11/20/1987SE |
| K863594 | Actin FSL Activated PTT ReagentGGW · Traditional | American Dade | 10/17/1986SE |
| K861190 | PTT Automate Test KitGGW · Traditional | American Bioproducts Co. | 06/23/1986SE |
| K853897 | Citrex HGGW · Traditional | Bio/Data Corp. | 10/10/1985SE |
| K852195 | Cephalinex Activated PTT ReagentGGW · Traditional | Bio/Data Corp. | 08/12/1985SE |
| K851126 | Aca Activated Partial Thromboplastin Time AnalyticGGW · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 05/29/1985SE |
| K841522 | Calcium ChlorideGGW · Traditional | Diatech, Inc. | 04/30/1984SE |
| K830320 | Activat-Partial Thrombo-PlastinGGW · Traditional | Helena Laboratories | 04/05/1983SE |
| K822782 | AcuscreenGGW · Traditional | Ortho Diagnostic Systems, Inc. | 10/08/1982SE |
| K811589 | Actin FS Activated PTT ReagentGGW · Traditional | American Dade | 07/16/1981SE |
| K802232 | Ab-Trol Coagulation ControlGGW · Traditional | Helena Laboratories | 11/12/1980SE |
| K801932 | Hep-TrolGGW · Traditional | Helena Laboratories | 09/09/1980SE |
| K801460 | Pacific Hemostasis Thrombo-Screen KapttGGW · Traditional | Pacific Hemostasis | 07/28/1980SE |
| K800925 | Verify S Prod. #34141GGW · Traditional | General Diagnostics | 07/21/1980SE |
| K800787 | Antibody to Varicella-Zoster VirusGGW · Traditional | Electro-Nucleonics Laboratories, Inc. | 07/14/1980SE |
| K800725 | A-Gent Quantichrom Thrombigen IGGW · Traditional | Abbott Laboratories | 06/04/1980SE |
| K792048 | Lancer Coagent Aptt KitGGW · Traditional | Sherwood Medical Co. | 11/05/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1073-2013 Class II | Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the…Siemens has observed that the listed lot numbers show an increase in Heparin sensitivity over the shelf life… | Siemens Healthcare Diagnostics, Inc. | 03/11/2013Terminated |
| Z-1043-2012 | Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and rabbit…The listed lots of Dade(R) Actin(R) FSL Reagent show an increase in Heparin sensitivity over the shelf life… | Siemens Healthcare Diagnostics, Inc. | 12/19/2011Terminated |