PQZ
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Gbs Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- FDA definition
- Culture Medium for GBS Detection
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Granada Medium (K173903) | Hardy Diagnostics | 2018-03-22 |
| Strep B Carrot Broth One-Step (K170586) | Hardy Diagnostics | 2017-05-22 |
| Strep B Carrot Broth Kit (K170481) | Hardy Diagnostics | 2017-05-16 |
| chromID Strepto B agar (K163042) | bioMerieux, Inc. | 2017-01-27 |
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Every clearance here is in the API, with alerts when new ones post.