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FDA 510(k)

EBV-VCA IGG ELISA TEST SYSTEM

K-Number: K981812 · 1999-03-04

ApplicantDiamedix Corp.
Decision Date1999-03-04
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV-VCA IGG ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1999-03-04 under 510(k) number K981812. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBV-VCA IGG ELISA TEST SYSTEM?

EBV-VCA IGG ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1999-03-04. The listed applicant is Diamedix Corp.. The 510(k) number is K981812.

When did EBV-VCA IGG ELISA TEST SYSTEM receive FDA 510(k) clearance?

EBV-VCA IGG ELISA TEST SYSTEM received FDA 510(k) clearance on 1999-03-04, under 510(k) number K981812.

Who is the listed applicant for EBV-VCA IGG ELISA TEST SYSTEM?

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

What is the FDA product code for EBV-VCA IGG ELISA TEST SYSTEM?

The FDA product code for EBV-VCA IGG ELISA TEST SYSTEM is LSE.

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Other records listing Diamedix 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.

K093101MAGO 4SK021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

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Related Devices (Code: LSE)

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.

K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.K091260SERAQUEST EBV EA-D IGG TESTQuest Intl., Inc.K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GFocus Diagnostics, Inc.K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, 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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