510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PQZClass I

Gbs Culture Media, Selective And Differential

21 CFR 866.2360 / Microbiology
FDA source (opens on fda.gov)

PQZ is the FDA product code for Gbs Culture Media, Selective And Differential, a class I device type, regulated under 21 CFR 866.2360. FDA's definition for this code reads: "Culture Medium for GBS Detection". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
PQZ
Device name
Gbs Culture Media, Selective And Differential
FDA definition
Culture Medium for GBS Detection
Regulation
21 CFR 866.2360
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
3

Clearances, product code PQZ

By decision year
4 clearances under product code PQZ with a decision year between 2017 and 2018, 2017 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PQZ by decision year
YearClearances
20173
20181

Applicants with the most clearances

Product code PQZ
Applicants holding the most 510(k) clearances under product code PQZ
ApplicantClearances
Hardy Diagnostics3
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code