The BinaxNOW? G6PD Test is a rapid test for the qualitative detection of G6PD enzyme activity in human venous whole blood. The simple, three step test provides results in less than 10 minutes, allowing for prompt treatment decisions.
Manufacturer Abbott Rapid Dx North America LLC
SPECIFICATIONS
Sample type: Venous Whole blood
Time to result: Heparin treated samples: 5 minutes
EDTA treated samples: 7 minutes
Kit size: 25 tests
Performance data*:
Heparin samples
Deficient result percent agreement 98%
Normal result percent agreement: 97.9%
EDTA samples
Deficient result percent agreement: 98.0%
Normal result percent agreement: 97.4%
*Compared to a commercially available quantitative G6PD test
Regulatory: Cleared for distribution by the FDA
PRODUCT CODE
BinaxNOW? G6PD Code 780-000
NON-RETURNABLE
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The BinaxNOW? G6PD Test is a rapid test for the qualitative detection of G6PD enzyme activity in human venous whole blood. The simple, three step test provides results in less than 10 minutes, allowing for prompt treatment decisions. Manufacturer Abbott Rapid Dx North America LLC SPECIFICATIONS Sample type: Venous Whole blood Time to result: Heparin treated samples: 5 minutes EDTA treated samples: 7 minutes Kit size: 25 tests Performance data*: Heparin samples Deficient result percent agreement 98% Normal result percent agreement: 97.9% EDTA samples Deficient result percent agreement: 98.0% Normal result percent agreement: 97.4% *Compared to a commercially available quantitative G6PD test Regulatory: Cleared for distribution by the FDA PRODUCT CODE BinaxNOW? G6PD Code 780-000 NON-RETURNABLE
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