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

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

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

PTJ is the FDA product code for Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates, a class II device type, regulated under 21 CFR 866.1640. FDA's definition for this code reads: "Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PTJ
Device name
Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
FDA definition
Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem
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
1

Clearances, product code PTJ

By decision year
3 clearances under product code PTJ with a decision year between 2017 and 2025, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PTJ by decision year
YearClearances
20171
20191
20251

Applicants with the most clearances

Product code PTJ
Applicants holding the most 510(k) clearances under product code PTJ
ApplicantClearances
NG Biotech2
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code