PQZ · Gbs Culture Media, Selective And Differential
Microbiology · 21 CFR 866.2360 · Class 1
Overview
| Product Code | PQZ |
|---|---|
| Device Name | Gbs Culture Media, Selective And Differential |
| Regulation | 21 CFR 866.2360 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K173903 | Granada Medium | Hardy Diagnostics | Mar 22, 2018 | SESE |
| K170586 | Strep B Carrot Broth One-Step | Hardy Diagnostics | May 22, 2017 | SESE |
| K170481 | Strep B Carrot Broth Kit | Hardy Diagnostics | May 16, 2017 | SESE |
| K163042 | chromID Strepto B agar | bioMerieux, Inc. | Jan 27, 2017 | SESE |
Top Applicants
- Hardy Diagnostics — 3 clearances
- bioMerieux, Inc. — 1 clearance
