Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EBV EA-D IGG ELISA KIT, MODEL EBG-100

K-Number: K021793 · 2002-09-27

ApplicantPan Bio Pty. , Ltd.
Decision Date2002-09-27
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV EA-D IGG ELISA KIT, MODEL EBG-100 is the device name listed in this FDA 510(k) record. The listed applicant is Pan Bio Pty. , Ltd.. It received FDA 510(k) clearance on 2002-09-27 under 510(k) number K021793. 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 EA-D IGG ELISA KIT, MODEL EBG-100?

EBV EA-D IGG ELISA KIT, MODEL EBG-100 is a medical device that received FDA 510(k) clearance on 2002-09-27. The listed applicant is Pan Bio Pty. , Ltd.. The 510(k) number is K021793.

When did EBV EA-D IGG ELISA KIT, MODEL EBG-100 receive FDA 510(k) clearance?

EBV EA-D IGG ELISA KIT, MODEL EBG-100 received FDA 510(k) clearance on 2002-09-27, under 510(k) number K021793.

Who is the listed applicant for EBV EA-D IGG ELISA KIT, MODEL EBG-100?

The FDA 510(k) record lists Pan Bio Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EBV EA-D IGG ELISA KIT, MODEL EBG-100?

The FDA product code for EBV EA-D IGG ELISA KIT, MODEL EBG-100 is LSE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pan Bio Pty. , Ltd. 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.

K020706EBV-VCA IGG ELISA TEST, MODEL EBG-100K020707EBV-EBNA IGG ELISA KIT, MODEL EBG-100K020717EBV V VCA IGM ELISA KIT MODEL# EBM-200

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.

↑