Lp(a) Control Set

FDA UDI

Class I (US FDA UDI)

by Sentinel Ch. Srl

Identity

Trade Name: Lp(a) Control Set FDA UDI
Generic Name: Lipoprotein A IVD, control FDA UDI
Device Name: Lp(a) Control Set must only be used to verify the performance of the Lp(a) test. Use the Control material like the specimens, according to the indicated analytical procedure. FDA UDI
Model / Reference: 1152201 FDA UDI
Description: Lp(a) Control Set must only be used to verify the performance of the Lp(a) test. Use the Control material like the specimens, according to the indicated analytical procedure. FDA UDI

Identifiers

Catalog Number: 1152201 FDA UDI
Primary DI / UDI-DI: 08058056681744 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Lipoprotein A IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 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

Yes

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, control

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

Similar devices

Also classified as Lipoprotein A IVD, control.

N Lp(a) Control SY — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
N Lp(a) Control SY — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Diazyme — Diazyme Laboratories, Inc.
Pointe Lipoprotein (a) Control Set — POINTE SCIENTIFIC, INC. · Class I
Diazyme — Diazyme Laboratories, Inc.
ARCHITECT — Abbott Laboratories, 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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Sentinel Ch. Srl

Sources (1)

FDA UDI ffdb0fdd-81b9-4607-b88c-a22db1351750 36 fields · synced Jun 7, 2026