GTN · Antisera, Fluorescent, All Types, Staphylococcus Spp.
Microbiology · 21 CFR 866.3700 · Class 1
Overview
| Product Code | GTN |
|---|---|
| Device Name | Antisera, Fluorescent, All Types, Staphylococcus Spp. |
| Regulation | 21 CFR 866.3700 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Staphylococcus aureus serological reagents are devices that consist of antigens and antisera used in serological tests to identify enterotoxin (toxin affecting the intestine) producing staphylococci from cultured isolates. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genus Staphylococcus and provides epidemiological information on these diseases. Certain strains of Staphylococcus aureus produce an enterotoxin while growing in meat, dairy, or bakery products. After ingestion, this enterotoxin is absorbed in the gut and causes destruction of the intestinal lining (gastroenteritis).
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 the limitations in § 866.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K855236 | DIAGNOSTIC REAGENT TST-RPLA | Oxoid U.S.A., Inc. | Nov 4, 1986 | SESE |
| K855233 | DIAGNOSTIC REAGENT SET-RPLA | Oxoid U.S.A., Inc. | Nov 4, 1986 | SESE |
| K851949 | STAPHAUREX ZL30 | Wellcome Diagnostics | May 22, 1985 | SESE |
| K791453 | AGGLUTINOTEST-STAPHYLOLISIN | Volu Sol Medical Industries | Sep 24, 1979 | SESE |
Top Applicants
- Oxoid U.S.A., Inc. — 2 clearances
- Volu Sol Medical Industries — 1 clearance
- Wellcome Diagnostics — 1 clearance
