Panels › Microbiology › Product code LIQ · Class 1
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Regulation 866.3405
0510(k)s in 12 months (33 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in LIQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Meridian Diagnostics, Inc. | 3 | 0 |
| Orion Diagnostica, Inc. | 3 | 0 |
| Abbott Laboratories | 2 | 0 |
| Biomerieux Vitek, Inc. | 2 | 0 |
| Intl. Diagnostic Laboratories, Ltd. | 2 | 0 |
| Kallestad Laboratories, Inc. | 2 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 2 |
| Ortho Diagnostic Systems, Inc. | 2 | 0 |
| Wellcome Diagnostics | 2 | 0 |
| Armkel, LLC | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2022 | MEDLINE INDUSTRIES, LP - Northfield meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box.
The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus Terminated |
LIQ | K971585 |
| Dec 1, 2021 | MEDLINE INDUSTRIES, LP - Northfield Premier Rotaclone, Rx only Terminated |
LIQ | K852969 |
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