Enzyme Linked Immunoabsorbent Assay, Rotavirus
FDA product code LIQ · Class I (low risk) · 21 CFR 866.3405 · Microbiology
33510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Orion Diagnostica, Inc. 3
- Meridian Diagnostics, Inc. 3
- Biomerieux Vitek, Inc. 2
- Ortho Diagnostic Systems, Inc. 2
- Abbott Laboratories 2
- Wellcome Diagnostics 2
- Kallestad Laboratories, Inc. 2
- Intl. Diagnostic Laboratories, Ltd. 2
- Armkel, LLC 1
- Orion Corp. 1
- Bartels Immunodiagnostic Supplies, Inc. 1
- Cambridge Bioscience Corp. 1
- Mercia Diagnostics , Ltd. 1
- Behring Diagnostics, Inc. 1
- Difco Laboratories, Inc. 1
- Vitek Systems, Inc. 1
- Dako Corp. 1
- Bio-Rad Laboratories, Inc. 1
- Dako Diagnostics , Ltd. 1
- Sa Scientific, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990842 | SAS Rota TestLIQ · Traditional | Sa Scientific, Inc. | 08/09/1999SE |
| K972895 | Vidas Rotavirus (RTV) AssayLIQ · Traditional | Biomerieux Vitek, Inc. | 10/03/1997SE |
| K971585 | Immunocard Stat! RotavirusLIQ · Traditional | Meridian Diagnostics, Inc. | 08/20/1997SE |
| K964424 | Rotavirus EiaLIQ · Traditional | Trinity Biotech, Inc. | 08/08/1997SE |
| K965092 | Vidas Rotavirus AssayLIQ · Traditional | Biomerieux Vitek, Inc. | 05/05/1997SE |
| K951208 | Rota-Dan Rapid Rotavirus Eia KitLIQ · Traditional | Eldan Technologies, Ltd. | 02/14/1996SE |
| K942286 | Diarlex Rota-AdenoLIQ · Traditional | Orion Diagnostica, Inc. | 12/14/1994SE |
| K933587 | Immunocard RotavirusLIQ · Traditional | Meridian Diagnostics, Inc. | 02/03/1994SE |
| K932384 | Ideia(Tm) RotavirusLIQ · Traditional | Dako Diagnostics , Ltd. | 12/27/1993SE |
| K915137 | Kallestad Rotavirus MicroplateLIQ · Traditional | Bio-Rad Laboratories, Inc. | 03/04/1992SE |
| K912666 | Dako Elisa Rotavirus Kit- 96 Tests K440LIQ · Traditional | Dako Corp. | 02/14/1992SE |
| K895805 | Slidex Rota-Kit 2LIQ · Traditional | Vitek Systems, Inc. | 02/26/1991SE |
| K884017 | RotacubeLIQ · Traditional | Difco Laboratories, Inc. | 01/24/1989SE |
| K883940 | Ortho* Rotavirus Latex Agglutination TestLIQ · Traditional | Ortho Diagnostic Systems, Inc. | 01/04/1989SE |
| K883935 | Ortho* Rotavirus Antigen Elisa TestLIQ · Traditional | Ortho Diagnostic Systems, Inc. | 01/04/1989SE |
| K880821 | Resubmitted Abbott Testpack RotavirusLIQ · Traditional | Abbott Laboratories | 05/06/1988SE |
| K874375 | Abbott Testpack Rotavirus Positive ControlLIQ · Traditional | Abbott Laboratories | 12/10/1987SE |
| K873740 | Rotascreen EiaLIQ · Traditional | Mercia Diagnostics , Ltd. | 11/27/1987SE |
| K864811 | Rota-StatLIQ · Traditional | Intl. Diagnostic Laboratories, Ltd. | 08/25/1987SE |
| K861628 | Wellcozyme Rotavirus WZ01LIQ · Traditional | Wellcome Diagnostics | 01/21/1987SE |
| K861634 | The Wellcome Rotavirus Latex Test ZL40LIQ · Traditional | Wellcome Diagnostics | 10/29/1986SE |
| K862917 | Pathfinder Rotavirus ChemiluminescentLIQ · Traditional | Kallestad Laboratories, Inc. | 10/22/1986SE |
| K861172 | Rotavirus Latex Agglutination AssayLIQ · Traditional | Bartels Immunodiagnostic Supplies, Inc. | 07/01/1986SE |
| K860529 | RotalexLIQ · Traditional | Orion Corp. | 03/04/1986SE |
| K854129 | Rotalex 2 Latex Agglutination Test for RotavirusLIQ · Traditional | Orion Diagnostica, Inc. | 01/21/1986SE |
| K853554 | Pathfinder Direct Antigen Detection Sys RotavirusLIQ · Traditional | Kallestad Laboratories, Inc. | 11/26/1985SE |
| K853399 | Virogen Rotatest Slide TestLIQ · Traditional | Armkel, LLC | 11/12/1985SE |
| K852969 | Rotaclone Rotavirus Diagnostic KitLIQ · Traditional | Cambridge Bioscience Corp. | 11/05/1985SE |
| K850269 | Meritec-Totavirus Latex Detection ProcedureLIQ · Traditional | Meridian Diagnostics, Inc. | 07/18/1985SE |
| K843367 | Rotavirus Enzyme ImmunoassayLIQ · Traditional | Intl. Diagnostic Laboratories, Ltd. | 06/13/1985SE |
| K841243 | Enzygnost Rotavirus AGLIQ · Traditional | Behring Diagnostics, Inc. | 10/17/1984SE |
| K841319 | Rotalex Latex Agglutination TestLIQ · Traditional | Orion Diagnostica, Inc. | 09/14/1984SE |
| K834443 | Rotavirus Bio-Enzabead Screen KitLIQ · Traditional | Litton Bionetics | 03/16/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0678-2022 Class II | meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The…The product was incorrectly shipped at room temperature rather than refrigerated. | MEDLINE INDUSTRIES, LP - Northfield | 01/25/2022Terminated |
| Z-0552-2022 Class II | Premier Rotaclone, Rx onlyProduct stored incorrectly in temperature controlled setting instead of refrigeration. | MEDLINE INDUSTRIES, LP - Northfield | 12/01/2021Terminated |