JTLClass I
Plasma, Coagulase, Human, Horse And Rabbit
Microbiology · 21 CFR 866.2160
MDR events32All time
Recalls0All time
Registered firms7Currently listed
510(k) clearances12All time
Recent MDR events
32 adverse event reports on file
- BD BBL¿ COAGULASE PLASMA, RABBIT WITH EDTADec 1, 2021MalfunctionLee Laboratories, Inc.1025402-2021-00007
- BD BBL COAGULASE PLASMA, RABBIT WITH EDTAJul 29, 2021MalfunctionLee Laboratories, Inc.1025402-2021-00006
- STA COAG CONTROL NMay 19, 2006MalfunctionDiagnostica Stago2245451-2006-00001
- *May 19, 2006OtherDiagnostica Stago9710666-2006-00001
- ORTHO SUMMIT PROCESSORNov 9, 2005OtherHamilton Bonaduz Ag2250051-2005-50528
- *Nov 9, 2005Malfunction2250051-2005-00528
- ORTHO SUMMIT PROCESSORSep 30, 2005OtherHamilton Bonaduz Ag2250051-2005-50450
- Unnamed deviceSep 30, 2005Malfunction2250051-2005-00450
- ORTHO SUMMIT PROCESSORJul 13, 2005OtherHamilton Bonaduz Ag2250051-2005-50303
- Unnamed deviceJul 13, 2005Malfunction2250052-2005-00303
Event type breakdown
Other17
Malfunction15
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
510(k) clearances
12 clearances for this product code
- Difco Laboratories, Inc.May 16, 1995
K950706 · DRYSLIDE COAGULASE
- Immuno-Mycologics, Inc.Aug 25, 1988
K883333 · RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT
- Oxoid U.S.A., Inc.Jun 10, 1987
K870945 · RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
- Micro-Bio-LogicsApr 18, 1986
K861312 · LYFO-KWIK (TM) COAGULASE PLASMA
- Remel Co.Apr 13, 1984
K840553 · HEMASTAPH
- Analytical Products, Inc.Dec 22, 1983
K833988 · API STAPHASE III
- Otisville Biotech, Inc.Dec 8, 1983
K833858 · COAGULASE PLASMA, HORSE & RABBIT EDTA
- American Scientific ProductsNov 5, 1982
K822988 · COAGULASE PLASMA-CITRATED & EDTA