LJKClass II
Antisera, If, Toxoplasma Gondii
Microbiology · 21 CFR 866.3780
MDR events4All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances6All time
Recent MDR events
4 adverse event reports on file
- IMMULITE 2000Oct 28, 2013MalfunctionSiemens Healthcare Diagnostics Inc.2247117-2013-00109
- COBAS 6000 E601 MODULEOct 4, 2011MalfunctionRoche Diagnostics1823260-2011-05212
- COBAS 6000 E601 MODULEAug 8, 2011MalfunctionRoche Diagnostics1823260-2011-04278
- PORT TITANIUM WITH GROSHONGJul 8, 1995MalfunctionDavol, Inc.23919
Event type breakdown
Malfunction4
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Boston Biomedica, Inc.Dec 11, 1997
K974261 · ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
- Bd Becton Dickinson Vacutainer Systems PreanalyticJul 1, 1991
K911771 · ARD(TM) ANTIMICROBIAL REMOVAL DEVICE
- Microbiological Research Corp.Feb 2, 1987
K861122 · THE GOLDEN QUAD TEST (TOXO)
- Widran Urological Group, Ltd.May 2, 1986
K861460 · SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101
- Bionetic Laboratory ProductsSep 26, 1983
K832069 · TOXO IPA KIT IAN INDIRECT FLUORESCENT
- Immulok, Inc.Oct 27, 1982
K822605 · TOXOPLASMA GONDII ANTIBODY IGG