LHJ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Staphylococcus Aureus Protein A Insoluble
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3700
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STAPHYTECT-OD (K940557) | Unipath , Ltd. | 1994-07-28 |
| IMMUSTAPH LATEX AGGLUTINATION KIT (K842709) | Immucell Corp. | 1984-08-03 |
| STAPHYLOCOCCAL PROTEIN A INSOLUBLE (K812181) | Oxoid U.S.A., Inc. | 1981-08-25 |
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