Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG

K-Number: K903882 · 1990-12-04

ApplicantViral Antigens, Inc.
Decision Date1990-12-04
Product CodeGQW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG is the device name listed in this FDA 510(k) record. The listed applicant is Viral Antigens, Inc.. It received FDA 510(k) clearance on 1990-12-04 under 510(k) number K903882. 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 VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG?

VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG is a medical device that received FDA 510(k) clearance on 1990-12-04. The listed applicant is Viral Antigens, Inc.. The 510(k) number is K903882.

When did VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG receive FDA 510(k) clearance?

VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG received FDA 510(k) clearance on 1990-12-04, under 510(k) number K903882.

Who is the listed applicant for VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG?

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

What is the FDA product code for VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG?

The FDA product code for VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG 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

Other records listing Viral Antigens, Inc. 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.

K964874HSV-1 ANTIGEN CONTROL SLIDESK971101HSV-2 ANTIGEN CONTROL SLIDESK964870RSV ANTIGEN CONTROL SLIDESK964872VZV ANTIGEN CONTROL SLIDESK964875CMV ANTIGEN CONTROL SLIDES

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.K942743VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENTViro Research, Inc.K912239VZVSCAN(TM) LATEX AGGUTINATION TESTBd Becton Dickinson Vacutainer Systems PreanalyticK894622VARICELLA ZOSTER VIRUSBion Ent., Ltd.

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.

↑