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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 9, 1999 | K990842 | SAS ROTA TEST Sa Scientific, Inc. | LIQ |
| Oct 3, 1997 | K972895 | VIDAS ROTAVIRUS (RTV) ASSAY Biomerieux Vitek, Inc. | LIQ |
| Aug 20, 1997 | K971585 | IMMUNOCARD STAT! ROTAVIRUS Meridian Diagnostics, Inc. | LIQ |
| Aug 8, 1997 | K964424 | ROTAVIRUS EIA Trinity Biotech, Inc. | LIQ |
| May 5, 1997 | K965092 | VIDAS ROTAVIRUS ASSAY Biomerieux Vitek, Inc. | LIQ |
| Feb 14, 1996 | K951208 | ROTA-DAN RAPID ROTAVIRUS EIA KIT Eldan Technologies, Ltd., IL | LIQ |
| Dec 14, 1994 | K942286 | DIARLEX ROTA-ADENO Orion Diagnostica, Inc., FI | LIQ |
| Feb 3, 1994 | K933587 | IMMUNOCARD ROTAVIRUS Meridian Diagnostics, Inc. | LIQ |
| Dec 27, 1993 | K932384 | IDEIA(TM) ROTAVIRUS Dako Diagnostics , Ltd., GB | LIQ |
| Mar 4, 1992 | K915137 | KALLESTAD ROTAVIRUS MICROPLATE Bio-Rad Laboratories, Inc. | LIQ |
| Feb 14, 1992 | K912666 | DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 Dako Corp., DK | LIQ |
| Feb 26, 1991 | K895805 | SLIDEX ROTA-KIT 2 Vitek Systems, Inc. | LIQ |
| Jan 24, 1989 | K884017 | ROTACUBE Difco Laboratories, Inc. | LIQ |
| Jan 4, 1989 | K883940 | ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST Ortho Diagnostic Systems, Inc. | LIQ |
| Jan 4, 1989 | K883935 | ORTHO* ROTAVIRUS ANTIGEN ELISA TEST Ortho Diagnostic Systems, Inc. | LIQ |
| May 6, 1988 | K880821 | RESUBMITTED ABBOTT TESTPACK ROTAVIRUS Abbott Laboratories | LIQ |
| Dec 10, 1987 | K874375 | ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL Abbott Laboratories | LIQ |
| Nov 27, 1987 | K873740 | ROTASCREEN EIA Mercia Diagnostics , Ltd., GB | LIQ |
| Aug 25, 1987 | K864811 | ROTA-STAT Intl. Diagnostic Laboratories, Ltd., IL | LIQ |
| Jan 21, 1987 | K861628 | WELLCOZYME ROTAVIRUS WZ01 Wellcome Diagnostics | LIQ |
| Oct 29, 1986 | K861634 | THE WELLCOME ROTAVIRUS LATEX TEST ZL40 Wellcome Diagnostics | LIQ |
| Oct 22, 1986 | K862917 | PATHFINDER ROTAVIRUS CHEMILUMINESCENT Kallestad Laboratories, Inc. | LIQ |
| Jul 1, 1986 | K861172 | ROTAVIRUS LATEX AGGLUTINATION ASSAY Bartels Immunodiagnostic Supplies, Inc. | LIQ |
| Mar 4, 1986 | K860529 | ROTALEX Orion Corp., FI | LIQ |
| Jan 21, 1986 | K854129 | ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS Orion Diagnostica, Inc. | LIQ |
| Nov 26, 1985 | K853554 | PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS Kallestad Laboratories, Inc. | LIQ |
| Nov 12, 1985 | K853399 | VIROGEN ROTATEST SLIDE TEST Armkel, LLC | LIQ |
| Nov 5, 1985 | K852969 | ROTACLONE ROTAVIRUS DIAGNOSTIC KIT Cambridge Bioscience Corp. | LIQ |
| Jul 18, 1985 | K850269 | MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE Meridian Diagnostics, Inc. | LIQ |
| Jun 13, 1985 | K843367 | ROTAVIRUS ENZYME IMMUNOASSAY Intl. Diagnostic Laboratories, Ltd. | LIQ |
| Oct 17, 1984 | K841243 | ENZYGNOST ROTAVIRUS AG Behring Diagnostics, Inc. | LIQ |
| Sep 14, 1984 | K841319 | ROTALEX LATEX AGGLUTINATION TEST Orion Diagnostica, Inc. | LIQ |
| Mar 16, 1984 | K834443 | ROTAVIRUS BIO-ENZABEAD SCREEN KIT Litton Bionetics | LIQ |
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