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

System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

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

PMY is the FDA product code for System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony, 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 isolated bacterial colonies using nucleic acid amplification technology". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PMY
Device name
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
FDA definition
To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies 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
3
Ingested recalls
0

Clearances, product code PMY

By decision year
3 clearances under product code PMY with a decision year between 2016 and 2021, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PMY by decision year
YearClearances
20161
20191
20211

Applicants with the most clearances

Product code PMY
Applicants holding the most 510(k) clearances under product code PMY
ApplicantClearances
Cepheid1
Genepoc, Inc.1
Opgen, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code