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Liquid Protein Calibrators (sp Cal (liq))

EUDAMEDFDA UDI

Class B (EU MDR)

Ref IT2692

by Randox Laboratories Limited

Identity

Trade Name
LIQUID PROTEIN CALIBRATORS (SP CAL (LIQ)) EUDAMED
SP CAL (LIQ) FDA UDI
Generic Name
Multiple clinical chemistry protein IVD, calibrator FDA UDI
Device Name
LIQUID PROTEIN CALIBRATORS (SP CAL (LIQ)) EUDAMED
Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of Alpha-1-Antitrypsin, Alpha-1-Acid glycoprotein, IgA, IgG and IgM assays that require sample pre-dilution. FDA UDI
Model / Reference
IT2692 EUDAMEDFDA UDI
Description
Liquid Protein Calibrators are an in vitro diagnostic product used for the calibration of Alpha-1-Antitrypsin, Alpha-1-Acid glycoprotein, IgA, IgG and IgM assays that require sample pre-dilution. FDA UDI

Identifiers

Catalog Number
IT2692 FDA UDI
Primary DI / UDI-DI
05055273204049 EUDAMEDFDA UDI
Basic UDI-DI
50552732BLUPCAL106LM EUDAMED
510(k) Number
K031608 FDA UDI
FDA Product Code
JIX FDA UDI
EMDN Code
W0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS EUDAMED
GMDN Term
Multiple clinical chemistry protein 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

Liquid Protein Calibrators (sp Cal (liq)) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED fb4e1131-12c7-4a4c-9ee5-406394d16a14 61 fields · synced Jun 18, 2026
  • FDA UDI 16e3d4d7-47d4-4820-aa72-cf94d6ea374f 37 fields · synced May 30, 2026