Identity
- Trade Name
- HDL CHOLESTEROL FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, reagent FDA UDI
- Device Name
- HDL CHOLESTEROL (PEG METHOD) FDA UDI
- Model / Reference
- 2150-P FDA UDI
- Description
- HDL CHOLESTEROL (PEG METHOD) FDA UDI
Identifiers
- Catalog Number
- 2150-P FDA UDI
- Primary DI / UDI-DI
- 00852223007027 FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, reagent FDA UDI
Classification
- 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
No
FDA UDI
Convenience Kit
Yes
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
Category: High density lipoprotein (HDL) cholesterol IVD, reagent
Hdl Cholesterol by Sterling Diagnostics Inc — 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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterling Diagnostics Inc
Sources (1)
- FDA UDI e4b76f7e-f08d-4762-b5b5-c7a8000a7981 34 fields · synced Jun 8, 2026