Identity
- Trade Name
- ALT/GPT 4+1 SL FDA UDI
- Generic Name
- Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry FDA UDI
- Model / Reference
- ALSL-0250 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540213106 FDA UDI
- GMDN Term
- Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
Alt/Gpt 4+1 Sl by Vitalscientific — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry.
- ALT/SGPT Liqui-UV® — STANBIO LABORATORY, L.P. · Class I
- ALT — Randox Laboratories, Ltd. · Class I
- ALT R1 (w/ssa#) — POINTE SCIENTIFIC, INC. · Class I
- ABX PENTRA ALT CP — Horiba Abx · Class I
- Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation — Roche Diagnostics Corp. · Class I
- ALANINE AMINOTRANSFERASE (ALT) — Randox Laboratories, Ltd. · Class I
- Alanine Aminotransferase / Aspartate Aminotransferase acc. to IFCC with PYP — Roche Diagnostics Corp. · Class I
- ALT R1 (w/ssa#) — POINTE SCIENTIFIC, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Vitalscientific
Sources (2)
- FDA UDI eb2e5aa2-6799-4a51-a575-ae3335895379 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026