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FDA 510(k)

HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT

K-Number: K803132 · 1981-01-28

ApplicantMicrobiological Research Corp.
Decision Date1981-01-28
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Microbiological Research Corp.. It received FDA 510(k) clearance on 1981-01-28 under 510(k) number K803132. The device is classified under product code GQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT?

HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT is a medical device that received FDA 510(k) clearance on 1981-01-28. The listed applicant is Microbiological Research Corp.. The 510(k) number is K803132.

When did HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT receive FDA 510(k) clearance?

HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT received FDA 510(k) clearance on 1981-01-28, under 510(k) number K803132.

Who is the listed applicant for HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT?

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

What is the FDA product code for HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT?

The FDA product code for HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT is GQL.

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Other records listing Microbiological Research Corp. 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.

K883011MRI NEO-TRYP TRYPSIN RIAK861120THE GOLDEN QUAD TEST (HSV)K861122THE GOLDEN QUAD TEST (TOXO)K861123THE GOLDEN QUAD TEST (CMV)K861121THE GOLDEN QUAD TEST (EBV)K860450THE CMV-IGM TEST

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Related Devices (Code: GQL)

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.

K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K081527LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KITMillipore CorporationK984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated 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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