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Fungal Organisms, Nucleic Acid-Based Assay

FDA product code PEO · 2 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3365
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-12-21 – 2024-06-04

A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.

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