Identity
- Trade Name
- Lipoprint System Buffer 4x16.5g FDA UDI
- Generic Name
- pH-adjusted buffer solution IVD FDA UDI
- Device Name
- The Lipoprint System Buffer is intended to be used as an electrolyte buffer solution in conjunction with Quantimetrix Lipoprint LDL and HDL reagent kits. It is a mixture of Tris (hydroxymethyl) aminomethane and Boric Acid crystals. FDA UDI
- Model / Reference
- 48-9519 FDA UDI
- Description
- The Lipoprint System Buffer is intended to be used as an electrolyte buffer solution in conjunction with Quantimetrix Lipoprint LDL and HDL reagent kits. It is a mixture of Tris (hydroxymethyl) aminomethane and Boric Acid crystals. FDA UDI
Identifiers
- Catalog Number
- 48-9519 FDA UDI
- Primary DI / UDI-DI
- 00896863002325 FDA UDI
- FDA Product Code
- JJY FDA UDIJHO FDA UDI
- GMDN Term
- pH-adjusted buffer solution IVD 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: pH-adjusted buffer solution IVD
Lipoprint System Buffer 4x16.5g 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 9bb61003-7b06-496e-bfc2-57a0d5e65adb 37 fields · synced May 30, 2026