Identity
- Trade Name
- autoHDL FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Device Name
- For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- 12-H7545-162 FDA UDI
- Description
- For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- 12-H7545-162 FDA UDI
- Primary DI / UDI-DI
- 00811727013552 FDA UDI
- 510(k) Number
- K992002 FDA UDI
- FDA Product Code
- LBR FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry 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, kit, spectrophotometry
autoHDL 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, kit, spectrophotometry.
- HDL-Cholesterol Gen.4 — Roche Diagnostics Corp. · Class I
- ENVOY 500 HDL CHOLESTEROL REAGENT KIT — VITALSCIENTIFIC
- CAROLINA LIQUID CHEMISTRIES CORP.® HDL RGT. KIT BL-616 — Carolina Liquid Chemistries Corp. · Class I
- HDL Ultra Cholesterol — Sekisui Diagnostics, LLC · Class I
- ABX PENTRA HDL DIRECT CP — Horiba Abx · Class I
- Sirrus® Direct HDL Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- Dimension Vista® Flex® reagent cartridge HDLC — Siemens Healthcare Diagnostics · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® HDLD RGT. KIT AU-616 — Carolina Liquid Chemistries Corp. · Class I
Cleared under the same submission
K992002 also covers:
- Pointe Scientific — 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.
- Pointe Scientific, Inc. autoHDL Cholesterol — POINTE SCIENTIFIC, INC.
- Pointe autoHDL Cholesterol Reagent — POINTE SCIENTIFIC, INC.
- Pointe autoHDL for the BS480 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 3d9b8a4e-3c0b-423f-9e8a-13f61a04f41f 37 fields · synced May 30, 2026