Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
The Phenotypic Test Kit for Non-Susceptible/Elevated MIC Organisms (Cultured Isolates) is a microbiological diagnostic device used for the qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any carbapenem antibiotic. This test aids clinical laboratories in identifying organisms with carbapenem resistance mechanisms, which is critical for infection control and guiding antibiotic therapy decisions. It is classified as FDA Class II under regulation 21 CFR 866.1640, meaning it requires premarket notification (510(k)) clearance and must comply with general and special controls. The product code is PTJ and it falls under the Microbiology medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PTJ
- Device Class
- FDA class 2
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.