Device |
ldt, unmet need within an integrated healthcare system |
Definition |
Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 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 | SCF |
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 |