Identity
- Trade Name
- ALT/GPT 4+1 SL EUDAMEDALT/GPT 4+1 SL, FDA UDI
- Generic Name
- Alanine aminotransferase (ALT) IVD, kit, spectrophotometry FDA UDI
- Device Name
- ALT/GPT 4+1 SL EUDAMED
- Model / Reference
- ALSL-0250 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700815303 EUDAMEDFDA UDI
- Basic UDI-DI
- 37017008ALSL008N EUDAMED
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE EUDAMED
- GMDN Term
- Alanine aminotransferase (ALT) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Category: Alanine aminotransferase (ALT) IVD, reagent
Alt/Gpt 4+1 Sl by Vitalscientific — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alanine aminotransferase (ALT) IVD, reagent.
- ALT (SGPT) LIQUID REAGENT (KINETIC METHOD) — TECO DIAGNOSTICS · Class I
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- 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 37017008ALSL008N | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED a23d20d7-da8b-4086-8d92-3932c293c68a 61 fields · synced Jun 8, 2026
- FDA UDI 2bff7a79-051a-40bc-a745-315d588f0b54 32 fields · synced May 30, 2026