Antithrombin Iii Quantitation
Hematology · 21 CFR 864.7060
Recent MDR events
4 adverse event reports on file
- INNOVANCE ANTITHROMBINMar 13, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00006
- INNOVANCE ANTITHROMBIN, HIGH VOLUMEDec 15, 2023MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2023-00022
- INNOVANCE ANTITHROMBINFeb 18, 2022MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2022-00007
- INNOVANCE(R) ANTITHROMBIN REAGENTJan 8, 2013MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2013-00001
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
25 firms currently registered for this product code
Beckman Coulter, Inc.
BREA, CA, US
Biomedica Diagnostics Inc.
Windsor Nova Scotia, CA
Diagnostica Stago, Inc.
PARSIPPANY, NJ, US
Hyphen Biomed Sasu
NEUVILLE SUR OISE Val-d'Oise, FR
Diagnostica Stago - Taverny
Taverny Val-d'Oise, FR
Beckman Coulter, Inc.
CARLSBAD, CA, US
Instrumentation Laboratory Co.
ORANGEBURG, NY, US
Kent Laboratories, Inc.
BELLINGHAM, WA, US
The Binding Site
Kings Norton Birmingham, GB
Tcoag Ireland Limited
BRAY Wicklow, IE
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Instrumentation Laboratory Co. - Devens
Devens, MA, US
The Binding Site Group Ltd.
BIRMINGHAM, GB
510(k) clearances
56 clearances for this product code
- Siemens Healthcare Diagnostic Products GmbHMar 28, 2025
K242952 · INNOVANCE Antithrombin
- Siemens Healthcare DiagnosticsMay 28, 2009
K081769 · INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
- Instrumentation Laboratory COFeb 23, 2007
K070301 · HEMOSIL ANTITHROMBIN
- Instrumentation Laboratory COSep 1, 2006
K062431 · HEMOSIL LIQUID ANTITHROMBIN
- Hyphen BiomedNov 7, 2005
K043007 · BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
- Instrumentation Laboratory COJan 2, 2004
K033775 · HEMOSIL LIQUID ANTITHROMBIN XL
- Precision BiologicApr 28, 2003
K023991 · CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
- Instrumentation Laboratory COAug 27, 2002
K022550 · COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS