Device |
ldt, not under a targeted enforcement discretion policy described in preamble to ldt final rule |
Definition |
Laboratory developed tests (LDTs) within the scope of the phaseout policy and not subject to a targeted enforcement discretion policy described in section V.B of the preamble to the LDT Final Rule (89 FR 37286). |
Physical State |
In vitro diagnostic device |
Technical Method |
In vitro diagnostic device |
Target Area |
In vitro diagnostic device |
Review Panel |
Clinical Chemistry |
Product Code | SCJ |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Not Classified Reason
|
Enforcement Discretion
|
Submission Type |
Enforcement Discretion
|
Device Class |
Not Classified
|
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 |