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FDA 510(k)

EBV VCA-P18 IGG ELISA

K-Number: K030863 · 2003-06-27

ApplicantPanbio Limited
Decision Date2003-06-27
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV VCA-P18 IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Panbio Limited. It received FDA 510(k) clearance on 2003-06-27 under 510(k) number K030863. 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-P18 IGG ELISA?

EBV VCA-P18 IGG ELISA is a medical device that received FDA 510(k) clearance on 2003-06-27. The listed applicant is Panbio Limited. The 510(k) number is K030863.

When did EBV VCA-P18 IGG ELISA receive FDA 510(k) clearance?

EBV VCA-P18 IGG ELISA received FDA 510(k) clearance on 2003-06-27, under 510(k) number K030863.

Who is the listed applicant for EBV VCA-P18 IGG ELISA?

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

What is the FDA product code for EBV VCA-P18 IGG ELISA?

The FDA product code for EBV VCA-P18 IGG ELISA is LSE.

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Other records listing Panbio Limited 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.

K041068WEST NILE VIRUS IGG INDIRECT ELISAK041231WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M

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.K062211BIOPLEX 2200 EBV IGG PANEL FOR 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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