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FDA 510(k)

VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT

K-Number: K942743 · 1994-12-15

ApplicantViro Research, Inc.
Decision Date1994-12-15
Product CodeGQW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Viro Research, Inc.. It received FDA 510(k) clearance on 1994-12-15 under 510(k) number K942743. The device is classified under product code GQW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT?

VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Viro Research, Inc.. The 510(k) number is K942743.

When did VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT receive FDA 510(k) clearance?

VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT received FDA 510(k) clearance on 1994-12-15, under 510(k) number K942743.

Who is the listed applicant for VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT?

The FDA 510(k) record lists Viro Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT?

The FDA product code for VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT is GQW.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: GQW)

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.

K070206DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000Diagnostic Hybrids, Inc.K990141LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295Light DiagnosticsK964872VZV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K912239VZVSCAN(TM) LATEX AGGUTINATION TESTBd Becton Dickinson Vacutainer Systems PreanalyticK903882VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGGViral Antigens, Inc.K894622VARICELLA ZOSTER VIRUSBion Ent., Ltd.

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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