POC · Class II · 21 CFR 866.1640

FDA Product Code POC: System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Directly From Clinical Specimens Using Nucleic Acid Amplification Technology.

Leading manufacturers include Cepheid and Check-Points Health B.V..

3
Total
3
Cleared
117d
Avg days
2016
Since

FDA 510(k) Cleared System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen Devices (Product Code POC)

3 devices
1–3 of 3
Cleared Aug 29, 2019
BD MAX Check-Points CPO
K190613
Check-Points Health B.V.
Microbiology · 171d
Cleared Jan 09, 2018
Xpert Carba-R
K173263
Cepheid
Microbiology · 90d

About Product Code POC - Regulatory Context