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Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

FDA product code PMN · 31 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3920
Review panel
MI
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2016-05-10 – 2026-07-17

Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.

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