Identity
- Trade Name
- AU FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Device Name
- HDL-Cholesterol FDA UDI
- Model / Reference
- OSR6195 FDA UDI
- Description
- HDL-Cholesterol FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590010911 FDA UDI
- 510(k) Number
- K040692 FDA UDI
- FDA Product Code
- LBS 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
Yes
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
Yes
FDA UDI
Category: High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
Au by Beckman Coulter, 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.
- Pointe autoHDL Cholesterol Reagent — POINTE SCIENTIFIC, INC. · Class I
- 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
Cleared under the same submission
K040692 also covers:
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
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 44093c74-8d27-4286-84c4-a5dabe431af1 34 fields · synced Jun 8, 2026