Antithrombin Iii Quantitation
FDA product code JBQ · Class II (moderate risk) · 21 CFR 864.7060 · Hematology
56510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Instrumentation Laboratory CO 9
- E.I. Dupont DE Nemours & Co., Inc. 2
- Beckman Instruments, Inc. 2
- Behring Diagnostics, Inc. 2
- American Bioproducts Co. 2
- Sigma Diagnostics, Inc. 2
- Helena Laboratories 2
- Ortho Diagnostics, Inc. 2
- Pharmaseal Div., Baxter Healthcare Corp. 2
- Sigma Chemical Co. 1
- Dade, Baxter Travenol Diagnostics, Inc. 1
- Pacific Hemostasis 1
- Bay Area Hema. Onco. Clinic. & Res. L 1
- Kabivitrum, Inc. 1
- American Dade 1
- Kent Laboratories, Inc. 1
- Gelco Diagnostics, Inc. 1
- Icl Scientific 1
- Hyland Therapeutic Div., Travenol Laboratories 1
- Warner-Lambert Co. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242952 | INNOVANCE AntithrombinJBQ · Traditional | Siemens Healthcare Diagnostic Products GmbH | 03/28/2025SE |
| K081769 | Innovance Antithrombin with Models OPFH03, OPFHO5JBQ · Traditional | Siemens Healthcare Diagnostics | 05/28/2009SE |
| K070301 | Hemosil AntithrombinJBQ · Special | Instrumentation Laboratory CO | 02/23/2007SE |
| K062431 | Hemosil Liquid AntithrombinJBQ · Special | Instrumentation Laboratory CO | 09/01/2006SE |
| K043007 | Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105JBQ · Traditional | Hyphen Biomed | 11/07/2005SE |
| K033775 | Hemosil Liquid Antithrombin XLJBQ · Special | Instrumentation Laboratory CO | 01/02/2004SE |
| K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50JBQ · Traditional | Precision Biologic | 04/28/2003SE |
| K022550 | Coamatic LR Antithrombin, Note: Lr=Liquid ReagentsJBQ · Traditional | Instrumentation Laboratory CO | 08/27/2002SE |
| K022195 | Coamatic AT-400JBQ · Traditional | Instrumentation Laboratory CO | 08/07/2002SE |
| K994238 | Il Test Liquid AntithrombinJBQ · Traditional | Instrumentation Laboratory CO | 06/23/2000SE |
| K000361 | K-Assay At-IiiJBQ · Traditional | Kamiya Biomedical Co. | 04/26/2000SE |
| K980499 | Il Test AntithrombinJBQ · Traditional | Instrumentation Laboratory CO | 04/02/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | Beckman Instruments, Inc. | 12/24/1997SE |
| K972144 | Sigma Diagnostics Accucolor Antithrombin IIIJBQ · Traditional | Sigma Diagnostics, Inc. | 07/25/1997SE |
| K960871 | Spectrolyse Antithrombin III (Anti-Xa)JBQ · Traditional | Medical Diagnostic Technologies, Inc. | 08/14/1996SE |
| K952515 | Coacute Antithrombin R Chromogenic AssayJBQ · Traditional | Chromogenix AB | 01/23/1996SE |
| K951943 | Chrom Z Chromogenic AssaysJBQ · Traditional | Helena Laboratories | 11/13/1995SE |
| K944279 | At-Iii CalibratorJBQ · Traditional | American Bioproducts Co. | 04/07/1995SE |
| K934156 | Biomerieux Hemolab at IIIJBQ · Traditional | Biomerieux Vitek, Inc. | 12/22/1994SE |
| K935308 | Accucolor(Tm) Antithrombin III Chromogenic AssayJBQ · Traditional | Sigma Diagnostics, Inc. | 05/17/1994SE |
| K936196 | Antithrombin III Chromogenic AssayJBQ · Traditional | Baxter Diagnostics, Inc. | 05/04/1994SE |
| K931420 | Coatest(R) Antithrombin III, ModificationJBQ · Traditional | Kabi Pharmacia Hepar, Inc. | 05/02/1994SE |
| K915083 | Coamate(R) Antithrombin Chromogenic AssayJBQ · Traditional | Kabi Pharmacia, Inc. | 01/03/1992SE |
| K913667 | Antithrombin III Immunological NL Test KitJBQ · Traditional | The Binding Site, Ltd. | 01/03/1992SE |
| K905110 | Liatest(R) at III Test KitJBQ · Traditional | American Bioproducts Co. | 01/24/1991SE |
| K902393 | Coacute Antithrombin Chromogenic AssayJBQ · Traditional | Kabi Diagnostica | 09/25/1990SE |
| K902530 | Spectrolyse Atiii KitJBQ · Traditional | Biopool AB | 08/09/1990SE |
| K901977 | Beckman Antithrombin III Reagent KitJBQ · Traditional | Beckman Instruments, Inc. | 08/06/1990SE |
| K900400 | Orthokrome* AntithrombinJBQ · Traditional | Ortho Diagnostic Systems, Inc. | 03/15/1990SE |
| K893608 | Actichrome Atiii KitJBQ · Traditional | American Diagnostic Corp. | 06/23/1989SE |
| K884144 | Turbox Antithrombin IIIJBQ · Traditional | Unipath , Ltd. | 12/20/1988SE |
| K883662 | Berichrom(R) Antithrombin IIIJBQ · Traditional | Behring Diagnostics, Inc. | 11/23/1988SE |
| K880700 | Enzygnost(R) Tat ReagentsJBQ · Traditional | Behring Diagnostics, Inc. | 04/27/1988SE |
| K880315 | Dade Antithrombin III Chromogenic AssayJBQ · Traditional | Baxter Healthcare Corp | 03/16/1988SE |
| K864214 | Il Test 97574-15M, Antitthrombin III AssasyJBQ · Traditional | Instrumentation Laboratory CO | 11/25/1986SE |
| K850412 | Gen. Diag. Chromostrate Antithrombin III AssayJBQ · Traditional | Warner-Lambert Co. | 05/08/1985SE |
| K841736 | Il Test Antithrombin III ActivityJBQ · Traditional | Instrumentation Laboratory CO | 09/06/1984SE |
| K832592 | Diacrom * AtiiiJBQ · Traditional | Wellcome Diagnostics | 09/29/1983SE |
| K832268 | Rabbit Anti-Human Antithrombin IIIJBQ · Traditional | Gelco Diagnostics, Inc. | 08/12/1983SE |
| K831961 | Immunodiffusion Test Human AntithrombinJBQ · Traditional | Kent Laboratories, Inc. | 08/11/1983SE |
| K831297 | Prototro/Proteolytic Enzyme ControlJBQ · Traditional | American Dade | 06/08/1983SE |
| K812829 | Coatest AntithrombinJBQ · Traditional | Kabivitrum, Inc. | 12/30/1981SE |
| K812626 | Aca Antithrombin III Plasminogen CalibJBQ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 11/24/1981SE |
| K812627 | Aca Antithrombin III Test PackJBQ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/08/1981SE |
| K812215 | Antithrombin III Screen KitJBQ · Traditional | Pacific Hemostasis | 09/01/1981SE |
| K802912 | Helena At-Iii Quiplate ProcedureJBQ · Traditional | Helena Laboratories | 12/22/1980SE |
| K792019 | Phadecode Xa Inhibitor AssayJBQ · Traditional | Pharmaseal Div., Baxter Healthcare Corp. | 11/05/1979SE |
| K790090 | Determination of Antithrombin III, 885JBQ · Traditional | Sigma Chemical Co. | 02/26/1979SE |
| K781860 | Assay, Chromogenic Antithrombin IIIJBQ · Traditional | Ortho Diagnostics, Inc. | 12/04/1978SE |
| K781480 | Antithrombin III AssayJBQ · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 11/08/1978SE |
| K781026 | Antithrombin III Serum, Anti-HumanJBQ · Traditional | Icl Scientific | 08/10/1978SE |
| K772328 | Las-R Human Antithrombin III TestJBQ · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 02/03/1978SE |
| K780002 | Antithrombin III AssayJBQ · Traditional | Ortho Diagnostics, Inc. | 01/31/1978SE |
| K771669 | Diag. Kit for Total Antithrombin IIIJBQ · Traditional | Abbott Laboratories | 11/09/1977SE |
| K770942 | Phadecode Differential Factor XA1 AssayJBQ · Traditional | Pharmaseal Div., Baxter Healthcare Corp. | 07/21/1977SE |
| K770394 | Thrombo-Screen AT-111 KitJBQ · Traditional | Bay Area Hema. Onco. Clinic. & Res. L | 03/30/1977SE |