Product code OQO— Microbiology
AMIPLIVUE HSV 1&2 ASSAY
- Classification name
- Herpes Simplex Virus Nucleic Acid Amplification Assay
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Total cleared
- 12
- First cleared
- Most recent
FDA classification 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.”
Market context for product code OQO
FDA has cleared devices under product code OQO between 2010 and 2018, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2017
- 2015
- 2014
- 2011
- 2010
Top applicants under product code OQO
Recent clearances under product code OQO
- K172509 — Sentosa SA201 HSV 1/2 Qualitative PCR Test
- K162673 — Aptima Herpes Simplex Viruses 1 & 2 Assay
- K150962 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
- K150617 — cobas HSV 1 and 2 Test
- K142156 — SEEGENE ANYPLEX II HSV-1/2 ASSAY
- K142738 — artus HSV-1/2 QS-RGQ MDx Kit
- K140198 — IMDX HSV-1/2 FOR ABBOTT M2000
- K140029 — AMIPLIVUE HSV 1&2 ASSAY
- K111951 — ISOAMP HSV ASSAY
- K111527 — MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
- K103798 — BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
- K100336 — MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
Data sourced from openFDA. This site is unofficial and independent of the FDA.