PQZ — Gbs Culture Media, Selective And Differential Class I
FDA Device Classification
Classification Details
- Product Code
- PQZ
- Device Class
- Class I
- Regulation Number
- 866.2360
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
Culture Medium for GBS Detection
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K173903 | hardy diagnostics | Granada Medium | March 22, 2018 |
| K170586 | hardy diagnostics | Strep B Carrot Broth One-Step | May 22, 2017 |
| K170481 | hardy diagnostics | Strep B Carrot Broth Kit | May 16, 2017 |
| K163042 | biomerieux | chromID Strepto B agar | January 27, 2017 |