Gbs Culture Media, Selective And Differential
The GBS Culture Media, Selective and Differential is a microbiological culture medium used for the selective and differential detection of Group B Streptococcus (GBS), a bacterium commonly screened for in pregnant women to prevent neonatal infection. It is classified as FDA Class 1 under 21 CFR 866.2360 in the Microbiology specialty, subject to general controls only, and is eligible for third-party review. Product code PQZ; not an implant and not life-sustaining.
Research product code PQZ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PQZ
- Device Class
- FDA class 1
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Culture Medium for GBS Detection
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K173903 | Granada Medium | Mar 22, 2018 | Substantially Equivalent | Hardy Diagnostics |
| K170586 | Strep B Carrot Broth One-Step | May 22, 2017 | Substantially Equivalent | Hardy Diagnostics |
| K170481 | Strep B Carrot Broth Kit | May 16, 2017 | Substantially Equivalent | Hardy Diagnostics |
| K163042 | chromID Strepto B agar | Jan 27, 2017 | Substantially Equivalent | bioMerieux, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.