Identity
- Trade Name
- ALT- GPT LR EUDAMED
- Device Name
- ALT-GPT LR EUDAMED
- Model / Reference
- FCC213-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ALT-GPTZ3 EUDAMED
- Basic UDI-DI
- B-ALT-GPTZ3 EUDAMED
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Category: Alanine aminotransferase (ALT) IVD, reagent
Alt- Gpt Lr by Futurlab S.r.l. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Alanine aminotransferase (ALT) IVD, reagent.
- ALT (SGPT) LIQUID REAGENT (KINETIC METHOD) — TECO DIAGNOSTICS · Class I
- GPT LIQUID R1:4x36, R2:2x18 ml (GSAU) — Biotechnological Applications Ltd · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
- 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/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-ALT-GPTZ3 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Futurlab S.r.l.
- EUDAMED SRN
- IT-MF-000046539
Sources (1)
- EUDAMED 00274c67-080c-4f89-9d65-b4a31890425d 61 fields · synced Jul 22, 2026