Liposure Serum Lipoprotein Control Level 1 4x0.5mL

FDA UDI

Class I (US FDA UDI)

by Quantimetrix Corp.

Identity

Trade Name: Liposure Serum Lipoprotein Control Level 1 4x0.5mL FDA UDI
Generic Name: Total lipoprotein IVD, control FDA UDI
Device Name: The Liposure Lipoprotein Control is intended for monitoring lipoprotein fractions (VLDL to HDL) as well as subfractions (Mid-bands, LDL subfractions 1, 2, and 3) using the Lipoprint LDL System to validate the separation and quantitation of lipoproteins in patient serum samples. It is prepared from human serum and supplied lyophilized. The lyophilized material contains stabilizers and preservatives. FDA UDI
Model / Reference: 48-7060 FDA UDI
Description: The Liposure Lipoprotein Control is intended for monitoring lipoprotein fractions (VLDL to HDL) as well as subfractions (Mid-bands, LDL subfractions 1, 2, and 3) using the Lipoprint LDL System to validate the separation and quantitation of lipoproteins in patient serum samples. It is prepared from human serum and supplied lyophilized. The lyophilized material contains stabilizers and preservatives. FDA UDI

Identifiers

Catalog Number: 48-7060 FDA UDI
Primary DI / UDI-DI: 00896863002318 FDA UDI
510(k) Number: K010337 FDA UDI
K013662 FDA UDI
FDA Product Code: JJY FDA UDI
JHO FDA UDI
GMDN Term: Total lipoprotein IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1475 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Total lipoprotein IVD, control

Liposure Serum Lipoprotein Control Level 1 4x0.5mL 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:

K013662 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 e40280b0-beae-4f39-b9ac-632530de6cc0 37 fields · synced Jun 6, 2026