NXX · Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Microbiology · 21 CFR 866.3700 · Class 1
Overview
| Product Code | NXX |
|---|---|
| Device Name | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus |
| 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 |
|---|---|---|---|---|
| K113371 | STAPHYLOCOCCUS QUICKFISH BC | Advandx, Inc. | Apr 3, 2012 | SESE |
| K092166 | S. AUREUS/CNS PNA FISH, MODEL KT005 | Advandx, Inc. | Nov 23, 2009 | SESE |
| K091827 | S. AUREUS PNA FISH | Advandx, Inc. | Aug 18, 2009 | SESE |
| K060099 | S. AUREUS PNA FISH | Advandx, Inc. | May 8, 2006 | SESE |
Top Applicants
- Advandx, Inc. — 4 clearances
