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-COMPLE FIX ANTIGEN AND NEG CONTRO

K-Number: K852930 · 1985-11-12

ApplicantMicrobix Biosystems, Inc.
Decision Date1985-11-12
Product CodeGQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO is the device name listed in this FDA 510(k) record. The listed applicant is Microbix Biosystems, Inc.. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K852930. 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-COMPLE FIX ANTIGEN AND NEG CONTRO?

VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Microbix Biosystems, Inc.. The 510(k) number is K852930.

When did VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO receive FDA 510(k) clearance?

VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO received FDA 510(k) clearance on 1985-11-12, under 510(k) number K852930.

Who is the listed applicant for VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO?

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

What is the FDA product code for VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO?

The FDA product code for VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO 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.

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 Microbix Biosystems, 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.

K894262RUBELLA ANTIGEN AND CONTROL ANTIGENK894261TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGENK852929CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTRK852932MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLTK852931HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLTK852933MYCOPLASMA SPP SEROLOGICAL REAGENTS

View all 7 devices →

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

View on FDA Database →

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

↑