Identity
- Trade Name
- Triglycerides Reagent FDA UDI
- Generic Name
- Triglyceride IVD, reagent FDA UDI
- Device Name
- For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycerides determinations are of interest in the diagnosis and treatment of atherosclerosis, poorly controlled diabetes mellitus, nephrosis, liver disease, or other diseases involving lipid metabolism. FDA UDI
- Model / Reference
- 500mL FDA UDI
- Description
- For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycerides determinations are of interest in the diagnosis and treatment of atherosclerosis, poorly controlled diabetes mellitus, nephrosis, liver disease, or other diseases involving lipid metabolism. FDA UDI
Identifiers
- Catalog Number
- 501-417 FDA UDI
- Primary DI / UDI-DI
- 00001812701208 FDA UDI
- FDA Product Code
- CDT FDA UDI
- GMDN Term
- Triglyceride IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1705 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Triglycerides Reagent by Clinical Diagnostic Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Clinical Diagnostic Solutions, Inc.
Sources (1)
- FDA UDI 3aecc73b-3d4a-42ab-bbf0-2b421a6ea188 37 fields · synced May 30, 2026