GQX · Class II · 21 CFR 866.3900

FDA Product Code GQX: Antiserum, Cf, Varicella-zoster

Leading manufacturers include Flow Laboratories, Inc., Gull Laboratories, Inc. and Ortho Diagnostic Systems, Inc..

11
Total
11
Cleared
147d
Avg days
1977
Since

FDA 510(k) Cleared Antiserum, Cf, Varicella-zoster Devices (Product Code GQX)

11 devices
1–11 of 11
Cleared Jul 17, 1991
VZV IGM TEST
K911301
Gull Laboratories, Inc.
Microbiology · 114d
Cleared Mar 31, 1988
VZV TEST
K875358
Gull Laboratories, Inc.
Microbiology · 91d
Cleared Apr 22, 1987
ENZYGNOST ANTI-VZV IGG TEST
K863317
Behring Diagnostics, Inc.
Microbiology · 239d
Cleared Jun 25, 1984
ORTHO VARICELLA-ZOSTER VIRUS IDENT.
K841526
Ortho Diagnostic Systems, Inc.
Microbiology · 74d
Cleared May 20, 1977
VARICELLA-ZOSTER FA LABELLED (8-321 RF)
K770806
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
VARICELLA-ZOSTER FA LABELED PRESERUM
K770810
Flow Laboratories, Inc.
Immunology · 17d

About Product Code GQX - Regulatory Context