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FDA 510(k)

VIRGO (R) CMV-IGG ELISA

K-Number: K883102 · 1989-02-08

ApplicantElectro-Nucleonics, Inc.
Decision Date1989-02-08
Product CodeGQI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIRGO (R) CMV-IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics, Inc.. It received FDA 510(k) clearance on 1989-02-08 under 510(k) number K883102. 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 VIRGO (R) CMV-IGG ELISA?

VIRGO (R) CMV-IGG ELISA is a medical device that received FDA 510(k) clearance on 1989-02-08. The listed applicant is Electro-Nucleonics, Inc.. The 510(k) number is K883102.

When did VIRGO (R) CMV-IGG ELISA receive FDA 510(k) clearance?

VIRGO (R) CMV-IGG ELISA received FDA 510(k) clearance on 1989-02-08, under 510(k) number K883102.

Who is the listed applicant for VIRGO (R) CMV-IGG ELISA?

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

What is the FDA product code for VIRGO (R) CMV-IGG ELISA?

The FDA product code for VIRGO (R) CMV-IGG ELISA is GQI.

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Other records listing Electro-Nucleonics, Inc. as applicant

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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 TESTNeogenexK875159DETECTADOT SYSTEM 2000 CMV IGG TESTGull Laboratories, Inc.K863488ENZYGNOST ANTI-CMV IGG TESTBehring Diagnostics, Inc.K861123THE GOLDEN QUAD TEST (CMV)Microbiological Research Corp.

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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