Alt / Gpt (ifcc)

EUDAMED

Class B (EU MDR)

Ref 981361Ref 981769

by Thermo Fisher Scientific Oy

Identity

Trade Name: ALT / GPT (IFCC) EUDAMED
ALT/GPT (IFCC) EUDAMED
Device Name: ALT / GPT (IFCC) EUDAMED
Model / Reference: 981361 EUDAMED
981769 EUDAMED

Identifiers

Primary DI / UDI-DI: 16438153813610 EUDAMED
16438153817694 EUDAMED
Basic UDI-DI: 6438153BU00157C3 EUDAMED
Direct Marketing DI: 16438153813610 EUDAMED
16438153817694 EUDAMED
EMDN Code: W01010103 ALANINE AMINO-TRANSFERASE EUDAMED

Classification

Device Class: Class B EUDAMED
Market of Registration: Finland EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Category: Alanine aminotransferase (ALT) IVD, reagent

Alt / Gpt (ifcc) by Thermo Fisher Scientific Oy — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Alanine aminotransferase (ALT) IVD, reagent.

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ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
Alinity — Abbott · Class I

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	6438153BU00157C3	Class B	Active

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Manufacturer

Manufacturer: Thermo Fisher Scientific Oy
EUDAMED SRN: FI-MF-000001479

Sources (2)

EUDAMED 31235ab6-e7fa-43db-82a6-f6b0e540479f 61 fields · synced Jul 13, 2026
EUDAMED 9777d3c3-ade8-4a2a-ab5e-002e75b0b1ed 61 fields · synced May 18, 2026