| Device |
joint biological agent identification and diagnostic system (jbaids) tularemia detection kit |
| Regulation Description |
Francisella tularensis serological reagents. |
| Definition |
To aid in the diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia with a qualitative in vitro diagnostic (ivd) detection of target dna sequences of francisella tularensis. |
| Physical State |
Kit contains 6 vacuum-sealed pouches of freeze-dried PCR reagents, containing 4 vials each, and six pouches containing one tube each of reconstitution buffer and reagent grade water. Designed to be used on the JBAIDS instrument (K051713). |
| Technical Method |
Real-time polymerase chain reaction (PCR)amplification and detection system. |
| Target Area |
Matrices: whole blood, sputum, colony and blood cultures. |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | OEH |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3280
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
