Identity
- Trade Name
- Pointe Scientific FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, reagent FDA UDI
- Device Name
- HDL reagent for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only. 6 x 60ml, 6 x 20ml FDA UDI
- Model / Reference
- HH945-480 FDA UDI
- Description
- HDL reagent for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only. 6 x 60ml, 6 x 20ml FDA UDI
Identifiers
- Catalog Number
- HH945-480 FDA UDI
- Primary DI / UDI-DI
- 00811727012913 FDA UDI
- 510(k) Number
- K992002 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
Yes
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
No
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
Pointe Scientific by Pointe Scientific, Inc. — 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
- 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
- Teco Diagnostics HDL Cholesterol Reagent Set — TECO DIAGNOSTICS · Class I
- HDL Cholesterol Precipitating Reagent — STANBIO LABORATORY, L.P. · Class I
Cleared under the same submission
K992002 also covers:
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. autoHDL Cholesterol — POINTE SCIENTIFIC, INC.
- Pointe autoHDL Cholesterol Reagent — POINTE SCIENTIFIC, INC.
- Pointe autoHDL for the BS480 — POINTE SCIENTIFIC, INC.
- autoHDL — POINTE SCIENTIFIC, INC.
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI d0b2b3e8-b178-4427-9301-b8fea539beb9 37 fields · synced May 30, 2026