Pointe G6PD Controls, 2x0.5ml L1, 2x0.5ml L2, Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood. For in vitro diagnostic use only.

Pointe G6PD Controls, 2x0.5ml L1, 2x0.5ml L2, Glucose
Pointe G6PD Controls - G7583-CTL

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells from a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JBF

Device Name: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

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: 864.7360

Third Party Flag: Y

Medical Specialty: HE

Device Id: 00811727015679

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