Hemoglobin variants assay, Ultra2 Genesys Variants Analyzer

Hemoglobin variants assay, Ultra2 Genesys Variants Analyzer
Trinity Biotech - Ultra2 Genesys Variants Analyzer

A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia, using a liquid chromatography method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GKA

Device Name: Abnormal Hemoglobin Quantitation

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.7415

Third Party Flag: Y

Medical Specialty: HE

Device Id: 05391516744102

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A