LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus Class I
FDA Device Classification
Classification Details
- Product Code
- LIQ
- Device Class
- Class I
- Regulation Number
- 866.3405
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K990842 | sa scientific | SAS ROTA TEST | August 9, 1999 |
| K972895 | biomerieux vitek | VIDAS ROTAVIRUS (RTV) ASSAY | October 3, 1997 |
| K971585 | meridian diagnostics | IMMUNOCARD STAT! ROTAVIRUS | August 20, 1997 |
| K964424 | trinity biotech | ROTAVIRUS EIA | August 8, 1997 |
| K965092 | biomerieux vitek | VIDAS ROTAVIRUS ASSAY | May 5, 1997 |
| K951208 | eldan technologies | ROTA-DAN RAPID ROTAVIRUS EIA KIT | February 14, 1996 |
| K942286 | orion diagnostica | DIARLEX ROTA-ADENO | December 14, 1994 |
| K933587 | meridian diagnostics | IMMUNOCARD ROTAVIRUS | February 3, 1994 |
| K932384 | dako diagnostics | IDEIA(TM) ROTAVIRUS | December 27, 1993 |
| K915137 | bio-rad laboratories | KALLESTAD ROTAVIRUS MICROPLATE | March 4, 1992 |
| K912666 | dako | DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 | February 14, 1992 |
| K895805 | vitek systems | SLIDEX ROTA-KIT 2 | February 26, 1991 |
| K884017 | difco laboratories | ROTACUBE | January 24, 1989 |
| K883940 | ortho diagnostic systems | ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST | January 4, 1989 |
| K883935 | ortho diagnostic systems | ORTHO* ROTAVIRUS ANTIGEN ELISA TEST | January 4, 1989 |
| K880821 | abbott laboratories | RESUBMITTED ABBOTT TESTPACK ROTAVIRUS | May 6, 1988 |
| K874375 | abbott laboratories | ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL | December 10, 1987 |
| K873740 | mercia diagnostics | ROTASCREEN EIA | November 27, 1987 |
| K864811 | intl. diagnostic laboratories | ROTA-STAT | August 25, 1987 |
| K861628 | wellcome diagnostics | WELLCOZYME ROTAVIRUS WZ01 | January 21, 1987 |