System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
The System, Nucleic Acid Amplification Test, DNA, Carbapenem Non-Susceptible Gram Negative Organism, Colony (product code PMY) is a Class 2 microbiology device that uses nucleic acid amplification technology to detect genetic markers of antimicrobial resistance by testing isolated bacterial colonies, regulated under 866.1640. It requires 510(k) clearance and aids in identifying carbapenem non-susceptible gram negative organisms. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PMY
- Device Class
- FDA class 2
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology.
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 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.