Identity
- Trade Name
- LDL-Cholesterol Gen.3 FDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 08057966190 FDA UDI
Identifiers
- Catalog Number
- 08057966190 FDA UDI
- Primary DI / UDI-DI
- 07613336121375 FDA UDI
- 510(k) Number
- K143691 FDA UDI
- FDA Product Code
- LBR FDA UDI
- GMDN Term
- Low density lipoprotein (LDL) 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
No
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: Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry
LDL-Cholesterol Gen.3 by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry.
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- CHOLESTEROL LDL SL 2G — VITALSCIENTIFIC
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- Pointe Scientific, Inc. autoLDL Cholesterol — POINTE SCIENTIFIC, INC. · Class I
Cleared under the same submission
K143691 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 |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 3a1ac1e7-269e-4f8a-9f30-e1bd55b16c2e 35 fields · synced Jun 8, 2026