Identity
- Trade Name
- STANDARD™ LipidoCare Analyzer FDA UDI
- Generic Name
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 02LA20G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887473000283 FDA UDI
- 510(k) Number
- K160282 FDA UDI
- FDA Product Code
- CHH FDA UDIJGY FDA UDILBR FDA UDI
- GMDN Term
- Total cholesterol lipid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 FDA UDI862.1705 FDA UDI862.1475 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Total cholesterol lipid IVD, kit, spectrophotometry
STANDARD™ LipidoCare Analyzer by Sd Biosensor — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total cholesterol lipid IVD, kit, spectrophotometry.
- Pointe Cholesterol Reagent — POINTE SCIENTIFIC, INC. · Class I
- Cholesterol Gen.2 — Roche Diagnostics Corp. · Class I
- Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- POINTE SCIENTIFIC Cholesterol (Liquid) — POINTE SCIENTIFIC, INC. · Class I
- CHOLESTEROL (CHOL) — Randox Laboratories, Ltd. · Class I
- CHOLESTEROL (CHOL) — Randox Laboratories, Ltd. · Class I
- CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT BL211 — Carolina Liquid Chemistries Corp. · Class I
Cleared under the same submission
K160282 also covers:
- CURO L7 Analyzer — Sd Biosensor
- CURO L7 Lipid Test Strip - Lipid Profile — Sd Biosensor
- STANDARD™ LipidoCare Analyzer — Sd Biosensor
- STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — Sd Biosensor
- STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — Sd Biosensor
- STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — Sd Biosensor
- STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile — Sd Biosensor
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
- Sd Biosensor
Sources (1)
- FDA UDI 0472a259-54b0-43d6-8434-2933dbb0ddae 33 fields · synced Jun 8, 2026