TGL FLEX REAGENT CARTRIDGE
Device Facts
| Record ID | K010871 |
|---|---|
| Device Name | TGL FLEX REAGENT CARTRIDGE |
| Applicant | Dade Behring, Inc. |
| Product Code | CDT · Clinical Chemistry |
| Decision Date | Jul 9, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1705 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
