GQO · Class II · 21 CFR 866.3305

FDA Product Code GQO: Antisera, Cf, Herpesvirus Hominis 1,2

Leading manufacturers include Amico Lab, Inc., Clinical Sciences, Inc. and Armkel, LLC.

16
Total
16
Cleared
245d
Avg days
1979
Since

FDA 510(k) Cleared Antisera, Cf, Herpesvirus Hominis 1,2 Devices (Product Code GQO)

16 devices
1–16 of 16
Cleared May 23, 1988
THE DDI SERODOT HERPES IGG TEST KIT
K875366
Disease Detection International, Inc.
Microbiology · 144d
Cleared Oct 15, 1987
VIROGEN HSV ANTIBODY TEST
K871426
Armkel, LLC
Microbiology · 189d
Cleared May 20, 1986
VISIBLE-HERPES TM TEST SYSTEM
K854712
Isolab, Inc.
Microbiology · 179d
Cleared Jan 21, 1986
HSV2 - IGG ELISA-KIT
K852781
Clinical Sciences, Inc.
Microbiology · 204d
Cleared Jan 21, 1986
HSVI - IGG ELISA-KIT
K852782
Clinical Sciences, Inc.
Microbiology · 204d
Cleared Dec 06, 1985
AMIZYME-HSV TYPES 1 & 2 TEST KITS
K842531
Amico Lab, Inc.
Immunology · 526d
Cleared Dec 06, 1985
ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2
K842663
Amico Lab, Inc.
Immunology · 514d
Cleared Nov 05, 1985
ENZYGNOST ANTIHERPES SIMPLEX VIRUS
K841245
Behring Diagnostics, Inc.
Immunology · 592d
Cleared Oct 17, 1985
VIROGEN HERPES SLIDE TEST
K852928
Armkel, LLC
Microbiology · 100d
Cleared Sep 07, 1979
ANTIBODY TO HERPESVIRUS HOMINIS
K791058
Electro-Nucleonics Laboratories, Inc.
Microbiology · 91d

About Product Code GQO - Regulatory Context