GOLClass II
Antigen, Ha (including Ha Control), Rubella
Microbiology · 21 CFR 866.3510
MDR events30All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances21All time
Recent MDR events
30 adverse event reports on file
- AXSYM RUBELLA LGG ANTIBODYMar 12, 2009MalfunctionAbbott Laboratories1415939-2008-00288
- AXSYM RUBELLA LGG ANTIBODYMar 12, 2009MalfunctionAbbott Laboratories1415939-2008-00289
- AXSYM RUBELLA LGG ANTIBODYMar 12, 2009MalfunctionAbbott Laboratories1415939-2008-00290
- AXSYM RUBELLA LGG ANTIBODYMar 12, 2009MalfunctionAbbott Laboratories1415939-2008-00291
- AXSYM RUBELLA LGG ANTIBODYMar 12, 2009MalfunctionAbbott Laboratories1415939-2008-00292
- AXSYM RUBELLA LGG ANTIBODYMar 12, 2009MalfunctionAbbott Laboratories1415939-2008-00293
- AXSYM RUBELLA LGG ANTIBODYMar 12, 2009MalfunctionAbbott Laboratories1415939-2008-00294
- AXSYM RUBELLA LGG ANTIBODYMar 12, 2009MalfunctionAbbott Laboratories1415939-2008-00299
- AXSYM RUBELLA LGG ANTIBODYMar 12, 2009MalfunctionAbbott Laboratories1415939-2008-00300
- AXSYM RUBELLA LGG ANTIBODYMar 12, 2009MalfunctionAbbott Laboratories1415939-2008-00301
Event type breakdown
Malfunction30
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
21 clearances for this product code
- Intl. Diagnostic TechnologyJun 7, 1984
K841174 · RUBELLA ANTIBODY FLUOROIMMUNOASSAY
- Abbott LaboratoriesApr 17, 1984
K834032 · RUBAQUICK DIAGNOSTIC KIT
- Calbiochem-Behring Corp.Mar 11, 1981
K810309 · RUBELLA ANTIBODIES TEST REAGENTS
- M.A. BioproductsDec 18, 1980
K802508 · RUBELISA IGM TEST KIT
- Calbiochem-Behring Corp.Dec 18, 1980
K802102 · RUBELLA ELISA REAGENTS RUBELLA IGG ANTI
- Beckman Instruments, Inc.Dec 18, 1980
K802339 · EIA RUBELLA-G
- Clinical Assays, Inc.Oct 23, 1980
K801667 · GAMMA COAT(125 I) RUBELLA ANTIBODY
- Flow Laboratories, Inc.Sep 16, 1980
K801098 · ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)