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FDA 510(k)

VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY

K-Number: K951799 · 1996-03-20

ApplicantLight Diagnostics
Decision Date1996-03-20
Product CodeGQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Light Diagnostics. It received FDA 510(k) clearance on 1996-03-20 under 510(k) number K951799. 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 VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY?

VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY is a medical device that received FDA 510(k) clearance on 1996-03-20. The listed applicant is Light Diagnostics. The 510(k) number is K951799.

When did VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY receive FDA 510(k) clearance?

VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY received FDA 510(k) clearance on 1996-03-20, under 510(k) number K951799.

Who is the listed applicant for VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY?

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

What is the FDA product code for VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY?

The FDA product code for VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY is GQX.

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Other records listing Light Diagnostics as applicant

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.

K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYK990141LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295K972975LIGHT DIAGNOSTICS RABIES DFA REAGENTK974302LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU BK951821CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAYK940017POLIOVIRUS 3 MONOCLONAL ANTIBODY

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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.

K911301VZV 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. BioproductsK852930VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTROMicrobix Biosystems, Inc.

Official Source

View on FDA Database →

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

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