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LIPOPROTEIN (a) CALIBRATOR SERIES (Lp(a) CAL SET)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref LP3404

by Randox Laboratories Limited

Identity

Trade Name
LIPOPROTEIN (a) CALIBRATOR SERIES (Lp(a) CAL SET) EUDAMED
Lp(a) CAL SET FDA UDI
Generic Name
Lipoprotein A IVD, calibrator FDA UDI
Device Name
LIPOPROTEIN (a) CALIBRATOR SERIES EUDAMED
This product is intended for use in the calibration of Lipoprotein(a) assays. FDA UDI
Model / Reference
LP3404 EUDAMEDFDA UDI
Description
This product is intended for use in the calibration of Lipoprotein(a) assays. FDA UDI

Identifiers

Catalog Number
LP3404 FDA UDI
Primary DI / UDI-DI
05055273204438 EUDAMEDFDA UDI
Basic UDI-DI
50552732BLCALSS081DM EUDAMED
510(k) Number
K011568 FDA UDI
FDA Product Code
JIS FDA UDI
EMDN Code
W0102152299 STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER EUDAMED
GMDN Term
Lipoprotein A IVD, calibrator FDA UDI

Classification

Device Class
Class B EUDAMED
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
Market of Registration
Northern Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

Yes

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

LIPOPROTEIN (a) CALIBRATOR SERIES (Lp(a) CAL SET) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED c210b561-8398-4392-a5f8-f59deeccdc24 61 fields · synced Jul 9, 2026
  • FDA UDI d3655da4-41eb-449c-b9aa-66aece9a7521 37 fields · synced May 30, 2026