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FDA 510(k)

EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM

K-Number: K901156 · 1990-09-12

ApplicantGranbio, Inc.
Decision Date1990-09-12
Product CodeGNP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Granbio, Inc.. It received FDA 510(k) clearance on 1990-09-12 under 510(k) number K901156. 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 EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM?

EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM is a medical device that received FDA 510(k) clearance on 1990-09-12. The listed applicant is Granbio, Inc.. The 510(k) number is K901156.

When did EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM receive FDA 510(k) clearance?

EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM received FDA 510(k) clearance on 1990-09-12, under 510(k) number K901156.

Who is the listed applicant for EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM?

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 EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM?

The FDA product code for EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM 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 KITK934774UNKNOWNK901840(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUMK881617INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAYK871298EBNA ACIF ASSAY KITK864347INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA

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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.K981831IS EBV-EA-D IGG ELISA TEST SYSTEMDiamedix Corp.K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEMDiamedix Corp.K883670SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VIElectro-Nucleonics, 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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