LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus
Microbiology · 21 CFR 866.3405 · Class 1
Overview
| Product Code | LIQ |
|---|---|
| Device Name | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Regulation | 21 CFR 866.3405 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (20 of 33)
Showing 20 most recent of 33 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K990842 | SAS ROTA TEST | Sa Scientific, Inc. | Aug 9, 1999 | SESE |
| K972895 | VIDAS ROTAVIRUS (RTV) ASSAY | Biomerieux Vitek, Inc. | Oct 3, 1997 | SESE |
| K971585 | IMMUNOCARD STAT! ROTAVIRUS | Meridian Diagnostics, Inc. | Aug 20, 1997 | SESE |
| K964424 | ROTAVIRUS EIA | Trinity Biotech, Inc. | Aug 8, 1997 | SESE |
| K965092 | VIDAS ROTAVIRUS ASSAY | Biomerieux Vitek, Inc. | May 5, 1997 | SESE |
| K951208 | ROTA-DAN RAPID ROTAVIRUS EIA KIT | Eldan Technologies, Ltd. | Feb 14, 1996 | SESE |
| K942286 | DIARLEX ROTA-ADENO | Orion Diagnostica, Inc. | Dec 14, 1994 | SESE |
| K933587 | IMMUNOCARD ROTAVIRUS | Meridian Diagnostics, Inc. | Feb 3, 1994 | SESE |
| K932384 | IDEIA(TM) ROTAVIRUS | Dako Diagnostics , Ltd. | Dec 27, 1993 | SESE |
| K915137 | KALLESTAD ROTAVIRUS MICROPLATE | Bio-Rad Laboratories, Inc. | Mar 4, 1992 | SESE |
| K912666 | DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 | Dako Corp. | Feb 14, 1992 | SESE |
| K895805 | SLIDEX ROTA-KIT 2 | Vitek Systems, Inc. | Feb 26, 1991 | SESE |
| K884017 | ROTACUBE | Difco Laboratories, Inc. | Jan 24, 1989 | SESE |
| K883940 | ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST | Ortho Diagnostic Systems, Inc. | Jan 4, 1989 | SESE |
| K883935 | ORTHO* ROTAVIRUS ANTIGEN ELISA TEST | Ortho Diagnostic Systems, Inc. | Jan 4, 1989 | SESE |
| K880821 | RESUBMITTED ABBOTT TESTPACK ROTAVIRUS | Abbott Laboratories | May 6, 1988 | SESE |
| K874375 | ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL | Abbott Laboratories | Dec 10, 1987 | SESE |
| K873740 | ROTASCREEN EIA | Mercia Diagnostics , Ltd. | Nov 27, 1987 | SESE |
| K864811 | ROTA-STAT | Intl. Diagnostic Laboratories, Ltd. | Aug 25, 1987 | SESE |
| K861628 | WELLCOZYME ROTAVIRUS WZ01 | Wellcome Diagnostics | Jan 21, 1987 | SESE |
Top Applicants
- Meridian Diagnostics, Inc. — 3 clearances
- Orion Diagnostica, Inc. — 3 clearances
- Abbott Laboratories — 2 clearances
- Biomerieux Vitek, Inc. — 2 clearances
- Intl. Diagnostic Laboratories, Ltd. — 2 clearances
