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

Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System

21 CFR 866.3975 / Microbiology
FDA source (opens on fda.gov)

PQA is the FDA product code for Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System, a class II device type, regulated under 21 CFR 866.3975. FDA's definition for this code reads: "A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or...". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
PQA
Device name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
FDA definition
A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.
Regulation
21 CFR 866.3975
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
3

Clearances, product code PQA

By decision year
12 clearances under product code PQA with a decision year between 2016 and 2026, 2019 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PQA by decision year
YearClearances
20161
20193
20211
20222
20232
20242
20261

Applicants with the most clearances

Product code PQA
Applicants holding the most 510(k) clearances under product code PQA
ApplicantClearances
Cepheid3
Hologic, Inc.3
Becton Dickinson & Co2
Geneohm Sciences Canada, Inc. (BD Diagnostics)2
Geneohm Sciences Canada, Inc. (BD Life Sciences)1
Roche Molecular Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code