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Bnp Controls For Abbott (bnp Control)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref CQ10521

by Randox Laboratories Limited

Identity

Trade Name
BNP CONTROLS FOR ABBOTT (BNP CONTROL) EUDAMEDFDA UDI
Generic Name
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control FDA UDI
Device Name
BNP CONTROLS EUDAMED
The BNP Controls for Abbott (CQ10521) are intended for use with in vitro diagnostic assays for the quantitative determination of BNP in human serum and plasma. The BNP Controls for Abbott (CQ10521) are assayed with target values and are suitable for use on Abbott analysers. The BNP Controls for Abbott (CQ10521) are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. FDA UDI
Model / Reference
CQ10521 EUDAMEDFDA UDI
Description
The BNP Controls for Abbott (CQ10521) are intended for use with in vitro diagnostic assays for the quantitative determination of BNP in human serum and plasma. The BNP Controls for Abbott (CQ10521) are assayed with target values and are suitable for use on Abbott analysers. The BNP Controls for Abbott (CQ10521) are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. FDA UDI

Identifiers

Catalog Number
CQ10521 FDA UDI
Primary DI / UDI-DI
05055273218497 EUDAMEDFDA UDI
Basic UDI-DI
50552732CBNPCON061FJ EUDAMED
FDA Product Code
JJX FDA UDI
EMDN Code
W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
GMDN Term
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control FDA UDI

Classification

Device Class
Class B EUDAMED
Class I FDA UDI
Regulation Number
862.1660 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Bnp Controls For Abbott (bnp Control) 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 5e002f44-1156-41ed-b8aa-afa6b67a6b18 61 fields · synced Jul 12, 2026
  • FDA UDI 7b9140fd-9aee-4fe3-a0f0-fd19914f5b21 36 fields · synced May 30, 2026