Identity
- Trade Name
- IDG/Sanzay FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, reagent FDA UDI
- Device Name
- The IDG HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The IDG HDL-Cholesterol reagent is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease. FDA UDI
Identifiers
- Catalog Number
- C501 FDA UDI
- Primary DI / UDI-DI
- 00850053916175 FDA UDI
- FDA Product Code
- LBR FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 80 Milliliter FDA UDITotal Volume — 380 Milliliter FDA UDITotal Volume — 1 Liter FDA UDI
Category: High density lipoprotein (HDL) cholesterol IVD, reagent
IDG/Sanzay by IDG/SANZAY Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as High density lipoprotein (HDL) cholesterol IVD, reagent.
- Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix — TECO DIAGNOSTICS · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- Pointe Scientific — POINTE SCIENTIFIC, INC. · Class I
- Diayzme — Diazyme Laboratories, Inc.
- ACE — Alfa Wassermann, Inc. · Class I
- PTS Panels® HDL Cholesterol Test Strips — Polymer Technology Systems · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
- Teco Diagnostics HDL Cholesterol Reagent Set — TECO DIAGNOSTICS · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- IDG/SANZAY Corporation
Sources (1)
- FDA UDI 17444410-bdd7-48d5-a15e-691eb53c55fd 36 fields · synced Jun 7, 2026