LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Microbiology · 21 CFR 866.3480 · Class 1
Overview
| Product Code | LKT |
|---|---|
| Device Name | Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Regulation | 21 CFR 866.3480 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.
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 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K081928 | D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT | Diagnostic Hybrids, Inc. | Dec 23, 2008 | SESE |
| K983336 | PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 | Diagnostic Products Corp. | Mar 18, 1999 | SESE |
| K943317 | PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) | Diagnostic Products Corp. | Dec 19, 1994 | SESE |
| K942173 | RSV ANTIGEN TEST | Neogenex | Jun 30, 1994 | SESE |
| K912842 | RSV-MAB TEST | Gull Laboratories, Inc. | Dec 9, 1991 | SESE |
| K912838 | BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO | Baxter Diagnostics, Inc. | Sep 27, 1991 | SESE |
| K912371 | BIOMERIEUX RSV DIRECT IF KIT | Vitek Systems, Inc. | Sep 23, 1991 | SESE |
| K894623 | RESPIRATORY SYNCYTIAL VIRUS | Bion Ent., Ltd. | Oct 16, 1989 | SESE |
| K884192 | RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION | Baxter Diagnostics, Inc. | Nov 22, 1988 | SESE |
| K882687 | ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST | Gull Laboratories, Inc. | Aug 30, 1988 | SESE |
| K873564 | GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES | Genetic Systems Corp. | Nov 20, 1987 | SESE |
| K872701 | RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL | Sita, Inc. | Sep 18, 1987 | SESE |
| K872082 | RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE | Medical Diagnostic Technologies, Inc. | Jul 31, 1987 | SESE |
| K870176 | GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT | Genetic Systems Corp. | Jul 16, 1987 | SESE |
| K871230 | ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS | Microscan Div. Baxter Healthcare Corp. | Jun 26, 1987 | SESE |
| K862321 | CELLMATICS RSV DETECTION SYSTEM | Difco Laboratories, Inc. | Aug 21, 1986 | SESE |
| K861379 | MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT | Serono Diagnostics, Inc. | Jul 16, 1986 | SESE |
| K852472 | ABBOTT RSV EIA | Abbott Laboratories | Sep 17, 1985 | SESE |
| K852185 | RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT | Bartels Immunodiagnostic Supplies, Inc. | Aug 19, 1985 | SESE |
| K844721 | INNOFLUOR PRIMIDONE | Innotron Diagnostics | Jan 8, 1985 | SESE |
Top Applicants
- Baxter Diagnostics, Inc. — 2 clearances
- Diagnostic Products Corp. — 2 clearances
- Genetic Systems Corp. — 2 clearances
- Gull Laboratories, Inc. — 2 clearances
- Ortho Diagnostic Systems, Inc. — 2 clearances
