LJY · Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Microbiology · 21 CFR 866.3380 · Class 1
Overview
| Product Code | LJY |
|---|---|
| Device Name | Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
| Regulation | 21 CFR 866.3380 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.
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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K991274 | MUMPS IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | Sep 3, 1999 | SESE |
| K980059 | SERAQUEST MUMPS IGG | Quest Intl., Inc. | Apr 23, 1998 | SESE |
| K971857 | MUMPS IGG ELISA TESTY | Gull Laboratories, Inc. | Nov 4, 1997 | SESE |
| K961204 | MUMPS IGG TEST | Zeus Scientific, Inc. | Jul 18, 1996 | SESE |
| K925209 | MUMPS STAT | Biowhittaker Molecular Applications, Inc. | Oct 14, 1994 | SESE |
| K923903 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA | Biomerieux Vitek, Inc. | Aug 9, 1993 | SESE |
| K897006 | PHARMACIA MUMPS IGG ELISA | Pharmacia Eni Diagnostics, Inc. | Jul 26, 1990 | SESE |
| K830045 | MUMPSELISA TEST KIT | M.A. Bioproducts | May 13, 1983 | SESE |
Top Applicants
- Biomerieux Vitek, Inc. — 1 clearance
- Biowhittaker Molecular Applications, Inc. — 1 clearance
- Columbia Bioscience, Inc. — 1 clearance
- Gull Laboratories, Inc. — 1 clearance
- M.A. Bioproducts — 1 clearance
