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FDA 510(k)

CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR

K-Number: K852929 · 1985-11-12

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

Device Summary

CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR 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 K852929. The device is classified under product code GQI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR?

CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR 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 K852929.

When did CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR receive FDA 510(k) clearance?

CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR received FDA 510(k) clearance on 1985-11-12, under 510(k) number K852929.

Who is the listed applicant for CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR?

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 CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR?

The FDA product code for CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR is GQI.

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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 ANTIGENK852930VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTROK852932MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLTK852931HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLTK852933MYCOPLASMA SPP SEROLOGICAL REAGENTS

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Related Devices (Code: GQI)

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.

K951800CMV IGG HUMAN SERUM CONTROLSPyramid Biological Corp.K952254ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUSPyramid Biological Corp.K942171CMV EARLY ANTIGEN TESTNeogenexK883102VIRGO (R) CMV-IGG ELISAElectro-Nucleonics, Inc.K875159DETECTADOT SYSTEM 2000 CMV IGG TESTGull Laboratories, Inc.K863488ENZYGNOST ANTI-CMV IGG TESTBehring Diagnostics, 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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