Dna-Reagents, Legionella
DNA reagents for Legionella are nucleic acid-based diagnostic reagents used to detect Legionella species in clinical or environmental specimens through molecular methods such as PCR, assisting in the diagnosis of Legionnaires' disease and related infections. They are classified as a Class 2 (moderate risk) device, subject to general and special controls, and require 510(k) premarket notification before marketing. The product code is LQH, regulated under 21 CFR 866.3300, within the Microbiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LQH
- Device Class
- FDA class 2
- Regulation Number
- 866.3300
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
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 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.