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Aldolase Level 3 Control (als Control 3)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref AD5002

by Randox Laboratories Limited

Identity

Trade Name
ALDOLASE LEVEL 3 CONTROL (ALS CONTROL 3) EUDAMEDFDA UDI
Generic Name
Aldolase IVD, control FDA UDI
Device Name
ALDOLASE CONTROL EUDAMED
Model / Reference
AD5002 EUDAMEDFDA UDI

Identifiers

Catalog Number
AD5002 FDA UDI
Primary DI / UDI-DI
05055273200102 EUDAMEDFDA UDI
Basic UDI-DI
50552732BALSCON005DZ EUDAMED
510(k) Number
K131776 FDA UDI
FDA Product Code
JJX FDA UDI
EMDN Code
W0101050201 ENZYME CONTROLS EUDAMED
GMDN Term
Aldolase 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Aldolase Level 3 Control (als Control 3) 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 073159b3-37f4-4c96-aef9-c5a9512eaf03 61 fields · synced Jun 18, 2026
  • FDA UDI 41bee628-89a9-45a7-bb03-f9d12ce8879e 34 fields · synced May 30, 2026