Device |
multiplex nucleic acid detection system for biothreat agents |
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 |
Physical State |
Multiplex nucleic acid detection systems are in vitro diagnostic devices that include reagents and associated instrumentation for detection and identification of biothreat nucleic acids from human clinical specimens |
Technical Method |
A qualitative in vitro diagnostic assay that detects and identifies nucleic acids from multiple biothreat pathogens |
Target Area |
Whole blood specimens |
Regulation Medical Specialty |
Immunology |
Review Panel |
Microbiology |
Product Code | QVR |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.4000
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |