Hemoglobin variants assay, Genesys 2 Reagent - 3.8L

Hemoglobin variants assay, Genesys 2 Reagent
Trinity Biotech - Genesys 2 Reagent - 3.8L

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of multiple subtypes of haemoglobin in a clinical specimen.

• Total Volume: 3.8 Liter

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: 05391516744201

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