PQZ · Class I · 21 CFR 866.2360

FDA Product Code PQZ: Gbs Culture Media, Selective And Differential

Culture Medium For Gbs Detection

Leading manufacturers include Hardy Diagnostics and bioMerieux, Inc..

4
Total
4
Cleared
88d
Avg days
2017
Since

FDA 510(k) Cleared Gbs Culture Media, Selective And Differential Devices (Product Code PQZ)

4 devices
1–4 of 4
Cleared Mar 22, 2018
Granada Medium
K173903
Hardy Diagnostics
Microbiology · 90d
Cleared May 22, 2017
Strep B Carrot Broth One-Step
K170586
Hardy Diagnostics
Microbiology · 83d
Cleared May 16, 2017
Strep B Carrot Broth Kit
K170481
Hardy Diagnostics
Microbiology · 89d
Cleared Jan 27, 2017
chromID Strepto B agar
K163042
bioMerieux, Inc.
Microbiology · 88d

About Product Code PQZ - Regulatory Context