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FDA 510(k)

IDEIA HERPES SIMPLEX VIRUS TEST

K-Number: K871877 · 1989-11-17

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1989-11-17
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IDEIA HERPES SIMPLEX VIRUS TEST is the device name listed in this FDA 510(k) record. The listed applicant is Boots-Celltech Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-11-17 under 510(k) number K871877. The device is classified under product code LGC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDEIA HERPES SIMPLEX VIRUS TEST?

IDEIA HERPES SIMPLEX VIRUS TEST is a medical device that received FDA 510(k) clearance on 1989-11-17. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K871877.

When did IDEIA HERPES SIMPLEX VIRUS TEST receive FDA 510(k) clearance?

IDEIA HERPES SIMPLEX VIRUS TEST received FDA 510(k) clearance on 1989-11-17, under 510(k) number K871877.

Who is the listed applicant for IDEIA HERPES SIMPLEX VIRUS TEST?

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

What is the FDA product code for IDEIA HERPES SIMPLEX VIRUS TEST?

The FDA product code for IDEIA HERPES SIMPLEX VIRUS TEST is LGC.

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Other records listing Boots-Celltech Diagnostics, 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.

K880799MODIFIED IDEIA CHLAMYDIA TESTK880758SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAYK874875CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)K872958IMAGEN INFLUENZA VIRUS A AND B TESTMIK872843OVEIA (TM) DUAL ANALYTEK873625CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)

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Related Devices (Code: LGC)

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.

K033059HERPES GROUP IGGTrinity Biotech, Inc.K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6Diagnostic Products Corp.K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMDiamedix Corp.K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GMrl DiagnosticsK992166THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K983886POCKIT HSV 2 RAPID TESTDiagnology , 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.

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