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Lower Respiratory Microbial Nucleic Acid Detection System

FDA product code QBH · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3985
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-12-20 – 2019-12-20

Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.

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