Skip to content

Multicode-Rtx Herpes Simplex Virus 1 & 2 Kit

by Eragen Biosciences, Inc. 510(k)

Active United States

510(k) K111527

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111527 Date3 Aug 2011ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
OQO
Device Class
Class II
Regulation
21 CFR Part 866.3305
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Other devices from Eragen Biosciences, Inc.