Device |
ivd offered as ldt, first marketed before may 6, 2024, not modified beyond scope described in preamble to ldt final rule |
Definition |
Currently marketed in vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that were first marketed prior to May 6, 2024, and not modified following that date or not modified beyond the scope 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 | SCE |
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 |