510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142738Substantially Equivalent

artus HSV-1/2 QS-RGQ MDx Kit

Qiagen, Germantown MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142738 is the FDA 510(k) clearance record for artus HSV-1/2 QS-RGQ MDx Kit, a class II device, cleared for Qiagen on under FDA product code OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay). FDA's definition for product code OQO 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". FDA records list 26 510(k) clearances for Qiagen, from to . As of , FDA records show no recalls naming K142738.

Clearance record

Decision date
Received
(87 days to decision)
Product code
OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Qiagen 19300 Germantown Rd., Germantown MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQO

Trailing 12 months

FDA records hold no clearances under product code OQO in the trailing twelve months.

FDA records show no clearances under product code OQO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OQO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260