Identity
- Trade Name
- LDL Cholesterol FDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- SK5665-20 FDA UDI
Identifiers
- Catalog Number
- SK5665-20 FDA UDI
- Primary DI / UDI-DI
- 00628063400775 FDA UDI
- 510(k) Number
- K992766 FDA UDI
- FDA Product Code
- MRR 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
- Not 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
LDL Cholesterol by Sekisui Diagnostics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K992766 also covers:
- N-geneous LDL-ST Cholesterol Calibrator — Sekisui Diagnostics, LLC
- N-geneous LDL-ST Cholesterol Reagent (R1) — Sekisui Diagnostics, LLC
- N-geneous LDL-ST Cholesterol Reagent (R1) — Sekisui Diagnostics, LLC
- N-geneous LDL-ST Cholesterol Reagent (R2) — Sekisui Diagnostics, LLC
- N-geneous LDL-ST Cholesterol Reagent (R2) — Sekisui Diagnostics, LLC
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
- Sekisui Diagnostics, LLC
Sources (1)
- FDA UDI 736917f7-2f7f-4a71-8661-2b277b63c402 35 fields · synced Jun 9, 2026