OQO · Class II · 21 CFR 866.3305

FDA Product Code OQO: Herpes Simplex Virus Nucleic Acid Amplification Assay

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.

12
Total
12
Cleared
119d
Avg days
2010
Since

FDA 510(k) Cleared Herpes Simplex Virus Nucleic Acid Amplification Assay Devices (Product Code OQO)

12 devices
1–12 of 12
No devices found for this product code.

About Product Code OQO - Regulatory Context