NDZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3370
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY (K000884) | Becton Dickinson Biosciences | 2001-01-19 |
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Every clearance here is in the API, with alerts when new ones post.