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FDA 510(k)

HYBRID CAPTURE SYSTEM CMV DNA ASSAY

K-Number: K974901 · 1998-09-29

ApplicantDigene Corp.
Decision Date1998-09-29
Product CodeLJO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HYBRID CAPTURE SYSTEM CMV DNA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Digene Corp.. It received FDA 510(k) clearance on 1998-09-29 under 510(k) number K974901. The device is classified under product code LJO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYBRID CAPTURE SYSTEM CMV DNA ASSAY?

HYBRID CAPTURE SYSTEM CMV DNA ASSAY is a medical device that received FDA 510(k) clearance on 1998-09-29. The listed applicant is Digene Corp.. The 510(k) number is K974901.

When did HYBRID CAPTURE SYSTEM CMV DNA ASSAY receive FDA 510(k) clearance?

HYBRID CAPTURE SYSTEM CMV DNA ASSAY received FDA 510(k) clearance on 1998-09-29, under 510(k) number K974901.

Who is the listed applicant for HYBRID CAPTURE SYSTEM CMV DNA ASSAY?

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

What is the FDA product code for HYBRID CAPTURE SYSTEM CMV DNA ASSAY?

The FDA product code for HYBRID CAPTURE SYSTEM CMV DNA ASSAY is LJO.

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Other records listing Digene 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.

K010891MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01K010892MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01K010893MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01K981567HYBRID CAPTURE II CT/GC TESTK981485HYBRID CAPTURE II GC-IDK990023HYBRID CAPTURE II CT-ID TEST

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Related Devices (Code: LJO)

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.

K203612Capture-CMVImmucor, Inc.K183571Capture-CMVImmucor, Inc.K001767DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEMDiamedix Corp.K974456CMVGENInstrumentation Laboratory COK951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYE.I. Dupont DE Nemours & Co., Inc.K955799COPALIS CMV TOTAL ANTIBODY ASSAYSienna Biotech, 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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