Product Code: GQX FDA class 2 21 CFR 866.3900

Antiserum, Cf, Varicella-Zoster

Microbiology

The Antiserum, CF, Varicella-Zoster is a complement fixation antiserum used as a laboratory reagent to assist in serological detection of varicella-zoster virus (VZV) antibodies. As an FDA Class 2 device, it presents moderate risk and requires a 510(k) premarket notification to demonstrate substantial equivalence before marketing. Regulated under 21 CFR 866.3900 with product code GQX in the Microbiology specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: GQX
Device Class: FDA class 2
Regulation Number: 866.3900
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 11 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K951799	VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY	Mar 20, 1996	Substantially Equivalent	Light Diagnostics
K911301	VZV IGM TEST	Jul 17, 1991	Substantially Equivalent	Gull Laboratories, Inc.
K883427	VIRGO(R) VZV-IGG ELISA	Mar 10, 1989	Substantially Equivalent	Electro-Nucleonics, Inc.
K875358	VZV TEST	Mar 31, 1988	Substantially Equivalent	Gull Laboratories, Inc.
K863317	ENZYGNOST ANTI-VZV IGG TEST	Apr 22, 1987	Substantially Equivalent	Behring Diagnostics, Inc.
K853540	FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY	Feb 04, 1986	Substantially Equivalent	Idt, A Division of Whittaker M.A. Bioproducts
K852930	VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO	Nov 12, 1985	Substantially Equivalent	Microbix Biosystems, Inc.
K842096	GLB VARICELLA-ZOSTER VIRUS FLUORESCENT	Jan 07, 1985	Substantially Equivalent	Great Lakes Bioscience
K841526	ORTHO VARICELLA-ZOSTER VIRUS IDENT.	Jun 25, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K770810	VARICELLA-ZOSTER FA LABELED PRESERUM	May 20, 1977	Substantially Equivalent	Flow Laboratories, Inc.
K770806	VARICELLA-ZOSTER FA LABELLED (8-321 RF)	May 20, 1977	Substantially Equivalent	Flow Laboratories, Inc.