OQO — Herpes Simplex Virus Nucleic Acid Amplification Assay Class II
Classification Details
- Product Code
- OQO
- Device Class
- Class II
- Regulation Number
- 866.3305
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172509 | vela diagnostics usa | Sentosa SA201 HSV 1/2 Qualitative PCR Test | February 1, 2018 |
| K162673 | hologic | Aptima Herpes Simplex Viruses 1 & 2 Assay | June 15, 2017 |
| K150962 | focus diagnostics | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | August 28, 2015 |
| K150617 | roche molecular systems | cobas HSV 1 and 2 Test | June 1, 2015 |
| K142156 | seegene | SEEGENE ANYPLEX II HSV-1/2 ASSAY | February 13, 2015 |
| K142738 | qiagen | artus HSV-1/2 QS-RGQ MDx Kit | December 19, 2014 |
| K140198 | intelligent medical devices | IMDX HSV-1/2 FOR ABBOTT M2000 | May 13, 2014 |
| K140029 | quidel corporation | AMIPLIVUE HSV 1&2 ASSAY | March 26, 2014 |
| K111951 | biohelix corporation | ISOAMP HSV ASSAY | September 27, 2011 |
| K111527 | eragen biosciences | MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT | August 3, 2011 |
| K103798 | becton, dickinson and | BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS | March 18, 2011 |
| K100336 | eragen biosciences | MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 | May 12, 2010 |