For the qualitative detection of G6PD enzyme activity in blood.

For the qualitative detection of G6PD enzyme activity in blood.
BinaxNOW® G6PD - 780-000

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) activity in red cells from a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

No Data Available

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: 10811877010705

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