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)

HERPES GROUP IGG

K-Number: K033059 · 2003-11-26

ApplicantTrinity Biotech, Inc.
Decision Date2003-11-26
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPES GROUP IGG is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Biotech, Inc.. It received FDA 510(k) clearance on 2003-11-26 under 510(k) number K033059. The device is classified under product code LGC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPES GROUP IGG?

HERPES GROUP IGG is a medical device that received FDA 510(k) clearance on 2003-11-26. The listed applicant is Trinity Biotech, Inc.. The 510(k) number is K033059.

When did HERPES GROUP IGG receive FDA 510(k) clearance?

HERPES GROUP IGG received FDA 510(k) clearance on 2003-11-26, under 510(k) number K033059.

Who is the listed applicant for HERPES GROUP IGG?

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

What is the FDA product code for HERPES GROUP IGG?

The FDA product code for HERPES GROUP IGG is LGC.

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 Trinity Biotech, 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.

K964424ROTAVIRUS EIA

Related Devices (Code: LGC)

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.

K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6Diagnostic Products Corp.K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMDiamedix Corp.K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GMrl DiagnosticsK992166THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K983886POCKIT HSV 2 RAPID TESTDiagnology , Ltd.K984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTMeridian Diagnostics, 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.

↑