Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
The lateral flow immunochromatography assay for host biomarkers of respiratory infection (product code QXA) is a Class 2 Microbiology in vitro diagnostic device (regulation 866.3230) intended to detect and qualitatively or quantitatively measure one or more non-microbial analytes in human clinical specimens to aid in the assessment or identification of a localized microbial infection when used in conjunction with clinical signs, symptoms, and other laboratory findings. It requires 510(k) clearance. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QXA
- Device Class
- FDA class 2
- Regulation Number
- 866.3230
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.
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.