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FDA 510(k)

INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA

K-Number: K864347 · 1987-02-02

ApplicantGranbio, Inc.
Decision Date1987-02-02
Product CodeGNP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA is the device name listed in this FDA 510(k) record. The listed applicant is Granbio, Inc.. It received FDA 510(k) clearance on 1987-02-02 under 510(k) number K864347. The device is classified under product code GNP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA?

INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA is a medical device that received FDA 510(k) clearance on 1987-02-02. The listed applicant is Granbio, Inc.. The 510(k) number is K864347.

When did INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA receive FDA 510(k) clearance?

INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA received FDA 510(k) clearance on 1987-02-02, under 510(k) number K864347.

Who is the listed applicant for INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA?

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

What is the FDA product code for INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA?

The FDA product code for INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA is GNP.

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Other records listing Granbio, 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.

K951822EBNA ENZYME IMMUNOASSAY KITK934774UNKNOWNK901156EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUMK901840(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUMK881617INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAYK871298EBNA ACIF ASSAY KIT

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Related Devices (Code: GNP)

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.

K020706EBV-VCA IGG ELISA TEST, MODEL EBG-100Pan Bio Pty. , Ltd.K020707EBV-EBNA IGG ELISA KIT, MODEL EBG-100Pan Bio Pty. , Ltd.K020717EBV V VCA IGM ELISA KIT MODEL# EBM-200Pan Bio Pty. , Ltd.K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEMDiamedix Corp.K981831IS EBV-EA-D IGG ELISA TEST SYSTEMDiamedix Corp.K901156EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUMGranbio, 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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