Lower Respiratory Microbial Nucleic Acid Detection System
The Lower Respiratory Microbial Nucleic Acid Detection System is an in vitro diagnostic device intended to detect and identify microorganisms and associated antimicrobial resistance marker nucleic acids directly in lower respiratory specimens, used to diagnose lower respiratory tract infections. It is classified as a Class 2 device under regulation 866.3985, requiring 510(k) premarket notification, and falls within the Microbiology (MI) medical specialty. The product code is QBH. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QBH
- Device Class
- FDA class 2
- Regulation Number
- 866.3985
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.