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FDA 510(k)

FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY

K-Number: K853540 · 1986-02-04

ApplicantIdt, A Division of Whittaker M.A. Bioproducts
Decision Date1986-02-04
Product CodeGQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Idt, A Division of Whittaker M.A. Bioproducts. It received FDA 510(k) clearance on 1986-02-04 under 510(k) number K853540. 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 FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY?

FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY is a medical device that received FDA 510(k) clearance on 1986-02-04. The listed applicant is Idt, A Division of Whittaker M.A. Bioproducts. The 510(k) number is K853540.

When did FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY receive FDA 510(k) clearance?

FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY received FDA 510(k) clearance on 1986-02-04, under 510(k) number K853540.

Who is the listed applicant for FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY?

The FDA 510(k) record lists Idt, A Division of Whittaker M.A. Bioproducts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY?

The FDA product code for FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY is GQX.

Related Clinical Trials

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.

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Other records listing Idt, A Division of Whittaker M.A. Bioproducts 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.

K853067FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENTK782041FIAX TEST KITK772219FIAX TEST FOR ANTI-RUBELLA ANTIBODYK772114FIAX C4 ASSAY

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.K852930VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTROMicrobix Biosystems, Inc.

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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