Lp(a) Ultra

FDA UDI

Class II (US FDA UDI)

by Sentinel Ch. Srl

Identity

Trade Name: Lp(a) Ultra FDA UDI
Generic Name: Lipoprotein A IVD, reagent FDA UDI
Device Name: The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. For In Vitro Diagnostic use. FDA UDI
Model / Reference: 11504D FDA UDI
Description: The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. For In Vitro Diagnostic use. FDA UDI

Identifiers

Catalog Number: 11504D FDA UDI
Primary DI / UDI-DI: 08058056680211 FDA UDI
510(k) Number: K211058 FDA UDI
FDA Product Code: DFC FDA UDI
GMDN Term: Lipoprotein A IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5600 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

Yes

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: Lipoprotein A IVD, reagent

Lp(a) Ultra by Sentinel Ch. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Lipoprotein A IVD, reagent.

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Pointe Lp(a) Reagent — POINTE SCIENTIFIC, INC. · Class II
Pointe Lp(a) Reagent — POINTE SCIENTIFIC, INC. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Sentinel Ch. Srl

Sources (1)

FDA UDI 426f19a1-c2a2-47c2-b269-303b81dfaf5e 37 fields · synced May 31, 2026