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

Herpes Simplex Virus Nucleic Acid Amplification Assay

21 CFR 866.3305 / Microbiology
FDA source (opens on fda.gov)

OQO is the FDA product code for Herpes Simplex Virus Nucleic Acid Amplification Assay, a class II device type, regulated under 21 CFR 866.3305. FDA's definition for this code reads: "A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OQO
Device name
Herpes Simplex Virus Nucleic Acid Amplification Assay
FDA definition
A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.
Regulation
21 CFR 866.3305
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
1

Clearances, product code OQO

By decision year
12 clearances under product code OQO with a decision year between 2010 and 2018, 2011 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OQO by decision year
YearClearances
20101
20113
20143
20153
20171
20181

Applicants with the most clearances

Product code OQO
Applicants holding the most 510(k) clearances under product code OQO
ApplicantClearances
Eragen Biosciences2
Becton Dickinson & Co1
Biohelix Corporation1
DiaSorin Molecular LLC1
Hologic, Inc.1
Intelligent Medical Devices, Inc.1
Qiagen1
Ortho-Clinical Diagnostics, Inc.1
Roche Molecular Systems Inc1
Seegene Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code