Product code LIQ
- Device name
- Enzyme Linked Immunoabsorbent Assay, Rotavirus
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3405
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990842 | SAS ROTA TEST | Sa Scientific, Inc. | 1999-08-09 |
| K972895 | VIDAS ROTAVIRUS (RTV) ASSAY | Biomerieux Vitek, Inc. | 1997-10-03 |
| K971585 | IMMUNOCARD STAT! ROTAVIRUS | Meridian Diagnostics, Inc. | 1997-08-20 |
| K964424 | ROTAVIRUS EIA | Trinity Biotech, Inc. | 1997-08-08 |
| K965092 | VIDAS ROTAVIRUS ASSAY | Biomerieux Vitek, Inc. | 1997-05-05 |
| K951208 | ROTA-DAN RAPID ROTAVIRUS EIA KIT | Eldan Technologies, Ltd. | 1996-02-14 |
| K942286 | DIARLEX ROTA-ADENO | Orion Diagnostica, Inc. | 1994-12-14 |
| K933587 | IMMUNOCARD ROTAVIRUS | Meridian Diagnostics, Inc. | 1994-02-03 |
| K932384 | IDEIA(TM) ROTAVIRUS | Dako Diagnostics , Ltd. | 1993-12-27 |
| K915137 | KALLESTAD ROTAVIRUS MICROPLATE | Bio-Rad Laboratories, Inc. | 1992-03-04 |
| K912666 | DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 | Dako Corp. | 1992-02-14 |
| K895805 | SLIDEX ROTA-KIT 2 | Vitek Systems, Inc. | 1991-02-26 |
| K884017 | ROTACUBE | Difco Laboratories, Inc. | 1989-01-24 |
| K883940 | ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST | Ortho Diagnostic Systems, Inc. | 1989-01-04 |
| K883935 | ORTHO* ROTAVIRUS ANTIGEN ELISA TEST | Ortho Diagnostic Systems, Inc. | 1989-01-04 |
| K880821 | RESUBMITTED ABBOTT TESTPACK ROTAVIRUS | Abbott Laboratories | 1988-05-06 |
| K874375 | ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL | Abbott Laboratories | 1987-12-10 |
| K873740 | ROTASCREEN EIA | Mercia Diagnostics , Ltd. | 1987-11-27 |
| K864811 | ROTA-STAT | Intl. Diagnostic Laboratories, Ltd. | 1987-08-25 |
| K861628 | WELLCOZYME ROTAVIRUS WZ01 | Wellcome Diagnostics | 1987-01-21 |
| K861634 | THE WELLCOME ROTAVIRUS LATEX TEST ZL40 | Wellcome Diagnostics | 1986-10-29 |
| K862917 | PATHFINDER ROTAVIRUS CHEMILUMINESCENT | Kallestad Laboratories, Inc. | 1986-10-22 |
| K861172 | ROTAVIRUS LATEX AGGLUTINATION ASSAY | Bartels Immunodiagnostic Supplies, Inc. | 1986-07-01 |
| K860529 | ROTALEX | Orion Corp. | 1986-03-04 |
| K854129 | ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS | Orion Diagnostica, Inc. | 1986-01-21 |
| K853554 | PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS | Kallestad Laboratories, Inc. | 1985-11-26 |
| K853399 | VIROGEN ROTATEST SLIDE TEST | Armkel, LLC | 1985-11-12 |
| K852969 | ROTACLONE ROTAVIRUS DIAGNOSTIC KIT | Cambridge Bioscience Corp. | 1985-11-05 |
| K850269 | MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE | Meridian Diagnostics, Inc. | 1985-07-18 |
| K843367 | ROTAVIRUS ENZYME IMMUNOASSAY | Intl. Diagnostic Laboratories, Ltd. | 1985-06-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840733101700 | PREMIER Rotaclone | MERIDIAN BIOSCIENCE, INC. | 2020-09-01 |
| 00840733101809 | ImmunoCard STAT! Rotavirus | MERIDIAN BIOSCIENCE, INC. | 2020-08-11 |
| 00722066001899 | Rapid Response | BTNX Inc | 2016-10-25 |