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Assay, Nucleic Acid Amplification, Bacillus Anthracis

FDA product code NHT · 5 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3045
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-11-18 – 2019-11-07

An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.

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