510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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POCClass II

System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

21 CFR 866.1640 / Microbiology
FDA source (opens on fda.gov)

POC is the FDA product code for System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen, a class II device type, regulated under 21 CFR 866.1640. FDA's definition for this code reads: "To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
POC
Device name
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
FDA definition
To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code POC

By decision year
4 clearances under product code POC with a decision year between 2016 and 2026, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code POC by decision year
YearClearances
20161
20181
20191
20261

Applicants with the most clearances

Product code POC
Applicants holding the most 510(k) clearances under product code POC
ApplicantClearances
Cepheid3
Check-Points Health B.V.1

Companies listing this code with FDA

Companies whose registered establishments list this code