Enzyme Linked Immunoabsorbent Assay, Rotavirus
Microbiology · 21 CFR 866.3405
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- MEDLINE INDUSTRIES, LP - NorthfieldTerminatedUnknown
Premier Rotaclone, Rx only
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Z-0552-2022 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldTerminatedUnknown
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box.
The product was incorrectly shipped at room temperature rather than refrigerated.
Z-0678-2022 · View FDA record ↗
Registered firms
14 firms currently registered for this product code
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Diasorin Inc.
Stillwater, MN, US
Acro Biotech Inc.
Montclair, CA, US
Meridian Bioscience, Inc.
Cincinnati, OH, US
Btnx Inc.
Pickering Ontario, CA
Ctk Biotech, Inc.
Poway, CA, US
Immunocentrix Corporation
Canoga Park, CA, US
Aceso Laboratories Inc.
Chino, CA, US
Sekisui Diagnostics, Llc
SAN DIEGO, CA, US
Remel Europe Ltd
DARTFORD, KENT, GB
Lumiquick Diagnostics, Inc.
SANTA CLARA, CA, US
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Sts Corporation
Duluth, GA, US
510(k) clearances
33 clearances for this product code
- Sa Scientific, Inc.Aug 9, 1999
K990842 · SAS ROTA TEST
- Biomerieux Vitek, Inc.Oct 3, 1997
K972895 · VIDAS ROTAVIRUS (RTV) ASSAY
- Meridian Diagnostics, Inc.Aug 20, 1997
K971585 · IMMUNOCARD STAT! ROTAVIRUS
- Trinity Biotech, Inc.Aug 8, 1997
K964424 · ROTAVIRUS EIA
- Biomerieux Vitek, Inc.May 5, 1997
K965092 · VIDAS ROTAVIRUS ASSAY
- Eldan Technologies, Ltd.Feb 14, 1996
K951208 · ROTA-DAN RAPID ROTAVIRUS EIA KIT
- Orion Diagnostica, Inc.Dec 14, 1994
K942286 · DIARLEX ROTA-ADENO
- Meridian Diagnostics, Inc.Feb 3, 1994
K933587 · IMMUNOCARD ROTAVIRUS