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)

VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT

K-Number: K992243 · 1999-08-30

ApplicantHemagen Diagnostics, Inc.
Decision Date1999-08-30
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 1999-08-30 under 510(k) number K992243. The device is classified under product code MSV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT?

VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT is a medical device that received FDA 510(k) clearance on 1999-08-30. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K992243.

When did VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT receive FDA 510(k) clearance?

VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT received FDA 510(k) clearance on 1999-08-30, under 510(k) number K992243.

Who is the listed applicant for VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT?

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

What is the FDA product code for VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT?

The FDA product code for VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT is MSV.

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 Hemagen Diagnostics, 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.

K041051RAICHEM BUN RATE REAGENT (LIQUID)K041052RAICHEM GLUCOSE UV (LIQUID)K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTK031101RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2K023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERK022772RAICHEM LDL-CHOLESTEROL DIRECT REAGENT

View all 52 devices →

Related Devices (Code: MSV)

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.

K243979Aptiva APS IgA ReagentInova Diagnostics, Inc.K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia ABK162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYPhadia US, Inc.K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLSInstrumentation Laboratory COK092757THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCRThera-Test 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.

↑