Identity
- Trade Name
- Lipoprint LDL Subfractions Kit 4x25 tests FDA UDI
- Generic Name
- Total lipoprotein IVD, control FDA UDI
- Device Name
- The Lipoprint System LDL Subfractions Kit is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions from VLDL to HDL) in fasting serum or plasma with a Total Cholesterol concentration of >100mg/dL. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment, and clinical evaluation. FDA UDI
- Model / Reference
- 48-7002 FDA UDI
- Description
- The Lipoprint System LDL Subfractions Kit is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions from VLDL to HDL) in fasting serum or plasma with a Total Cholesterol concentration of >100mg/dL. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment, and clinical evaluation. FDA UDI
Identifiers
- Catalog Number
- 48-7002 FDA UDI
- Primary DI / UDI-DI
- 00896863002332 FDA UDI
- FDA Product Code
- JJY FDA UDIJHO FDA UDI
- GMDN Term
- Total lipoprotein IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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: Total lipoprotein IVD, control
Lipoprint LDL Subfractions Kit 4x25 tests by Quantimetrix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K010337 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
- Quantimetrix Corp.
Sources (1)
- FDA UDI 907035e6-b24e-4670-afae-c11dd17003a7 37 fields · synced Jun 6, 2026