Identity
- Trade Name
- ALT FDA UDI
- Generic Name
- Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- An ALT test system is a device intended for the quantitative in vitro determination of Alanine Aminotransferase (ALT) activity in serum and plasma. FDA UDI
- Model / Reference
- AL3801 FDA UDI
- Description
- An ALT test system is a device intended for the quantitative in vitro determination of Alanine Aminotransferase (ALT) activity in serum and plasma. FDA UDI
Identifiers
- Catalog Number
- AL3801 FDA UDI
- Primary DI / UDI-DI
- 05055273200218 FDA UDI
- 510(k) Number
- K923510 FDA UDI
- FDA Product Code
- CKA FDA UDI
- GMDN Term
- Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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 by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — 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 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 / Aspartate Aminotransferase acc. to IFCC with PYP — Roche Diagnostics Corp. · Class I
- ALT R1 (w/ssa#) — POINTE SCIENTIFIC, INC. · Class I
- POINTE SCIENTIFIC ALT — POINTE SCIENTIFIC, INC. · Class I
- POINTE SCIENTIFIC ALT (SGPT) Liquid — POINTE SCIENTIFIC, INC. · Class I
Cleared under the same submission
K923510 also covers:
- ALANINE AMINOTRANSFERASE (ALT) — Randox Laboratories, Ltd.
- ALANINE AMINOTRANSFERASE (ALT) — Randox Laboratories, Ltd.
- ALANINE AMINOTRANSFERASE (ALT) — Randox Laboratories, Ltd.
- ALANINE AMINOTRANSFERASE (ALT) — Randox Laboratories, Ltd.
- ALANINE AMINOTRANSFERASE (ALT) — Randox Laboratories, Ltd.
- ALANINE AMINOTRANSFERASE (ALT) — Randox Laboratories, Ltd.
- ALANINE AMINOTRANSFERASE (ALT) — Randox Laboratories, Ltd.
- ALT — Randox Laboratories, Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 3eed3f56-bd77-44b3-b5e3-32fad4754da4 37 fields · synced Jun 1, 2026