21 CFR 866.3700 — Antisera, Fluorescent, All Types, Staphylococcus Spp.
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3700
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GTN | Antisera, Fluorescent, All Types, Staphylococcus Spp. | 1 | 4 | |
| LHJ | Staphylococcus Aureus Protein A Insoluble | 1 | 3 | |
| LHT | Staphylococcus Aureus Somatic Antigens | 1 | 13 | |
| MCS | Dna-Probe, Staphylococcus Aureus | 1 | 1 | |
| NXX | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus | 1 | 4 |
