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FDA 510(k)

GLB VARICELLA-ZOSTER VIRUS FLUORESCENT

K-Number: K842096 · 1985-01-07

ApplicantGreat Lakes Bioscience
Decision Date1985-01-07
Product CodeGQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GLB VARICELLA-ZOSTER VIRUS FLUORESCENT is the device name listed in this FDA 510(k) record. The listed applicant is Great Lakes Bioscience. It received FDA 510(k) clearance on 1985-01-07 under 510(k) number K842096. The device is classified under product code GQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLB VARICELLA-ZOSTER VIRUS FLUORESCENT?

GLB VARICELLA-ZOSTER VIRUS FLUORESCENT is a medical device that received FDA 510(k) clearance on 1985-01-07. The listed applicant is Great Lakes Bioscience. The 510(k) number is K842096.

When did GLB VARICELLA-ZOSTER VIRUS FLUORESCENT receive FDA 510(k) clearance?

GLB VARICELLA-ZOSTER VIRUS FLUORESCENT received FDA 510(k) clearance on 1985-01-07, under 510(k) number K842096.

Who is the listed applicant for GLB VARICELLA-ZOSTER VIRUS FLUORESCENT?

The FDA 510(k) record lists Great Lakes Bioscience as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLB VARICELLA-ZOSTER VIRUS FLUORESCENT?

The FDA product code for GLB VARICELLA-ZOSTER VIRUS FLUORESCENT is GQX.

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Related Devices (Code: GQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K951799VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK911301VZV IGM TESTGull Laboratories, Inc.K883427VIRGO(R) VZV-IGG ELISAElectro-Nucleonics, Inc.K875358VZV TESTGull Laboratories, Inc.K863317ENZYGNOST ANTI-VZV IGG TESTBehring Diagnostics, Inc.K853540FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGYIdt, A Division of Whittaker M.A. Bioproducts

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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