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FDA 510(k)

P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN

K-Number: K905385 · 1991-03-21

ApplicantVirion (U.S.), Inc.
Decision Date1991-03-21
Product CodeGQS
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Virion (U.S.), Inc.. It received FDA 510(k) clearance on 1991-03-21 under 510(k) number K905385. The device is classified under product code GQS. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN?

P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN is a medical device that received FDA 510(k) clearance on 1991-03-21. The listed applicant is Virion (U.S.), Inc.. The 510(k) number is K905385.

When did P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN receive FDA 510(k) clearance?

P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN received FDA 510(k) clearance on 1991-03-21, under 510(k) number K905385.

Who is the listed applicant for P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN?

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

What is the FDA product code for P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN?

The FDA product code for P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN is GQS.

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 Virion (U.S.), 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.

K933251EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TESTK921618COXSACKIE VIRUS B1-B6 CF ANTIGENSK905306MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGENK864981TOXOPLASMA GONDII

Related Devices (Code: GQS)

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.

K093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITDiagnostic Hybrids, Inc.K943557IMAGENDako Diagnostics , Ltd.K884193PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECTBaxter Diagnostics, Inc.K884194PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECTBaxter Diagnostics, Inc.K871234ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1Microscan Div. Baxter Healthcare Corp.K871232ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3Microscan Div. Baxter Healthcare Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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