Multiplex Nucleic Acid Detection System For Biothreat Agents
The Multiplex Nucleic Acid Detection System for Biothreat Agents is a qualitative in vitro diagnostic test designed to simultaneously detect and identify nucleic acids from multiple biothreat pathogens in human clinical specimens, supporting rapid laboratory response to potential bioterrorism or public health emergency events. Classified as FDA Class 2 under regulation 866.4000, it requires 510(k) clearance in the Immunology specialty with review by the Microbiology panel. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QVR
- Device Class
- FDA class 2
- Regulation Number
- 866.4000
- Medical Specialty
- Immunology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231336 | T2 Biothreat Panel | Sep 15, 2023 | Substantially Equivalent | T2biosystems, Inc. |
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | Mar 22, 2023 | Substantially Equivalent | Biofire Defense, LLC |
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.