Device |
blood/plasma collection device for dna testing |
Regulation Description |
Blood specimen collection device. |
Definition |
A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing. |
Physical State |
Blood collection device |
Technical Method |
The blood is drawn in the tube to be transported to the laboratory for clinical DNA testing. |
Target Area |
Whole blood/ plasma for in vitro diagnostics |
Regulation Medical Specialty |
Clinical Chemistry |
Review Panel |
Clinical Chemistry |
Product Code | PJE |
Premarket Review |
Division of Chemistry and Toxicology Devices
(DCTD)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Submission Type |
510(k)
|
Regulation Number |
862.1675
|
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 |