Identity
- Trade Name
- ALT (SGPT) Reagent Set FDA UDI
- Generic Name
- Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- For the quantitative determination of Alanine Aminotransferase in serum. ALT is widely distributed in tissues with the highest concentrations found in the liver and kidneys. Even so, ALT is considered more liver-specific than AST. Elevated levels of ALT are often only observed in liver diseases such as cirrhosis, hepatitis, or metastatic carcinoma. However, there can be elevated levels of ALT with infectious mononucleosis, muscular dystrophy, and dermatomyositis. FDA UDI
- Model / Reference
- R1 x 500mL, R2 x 125mL FDA UDI
- Description
- For the quantitative determination of Alanine Aminotransferase in serum. ALT is widely distributed in tissues with the highest concentrations found in the liver and kidneys. Even so, ALT is considered more liver-specific than AST. Elevated levels of ALT are often only observed in liver diseases such as cirrhosis, hepatitis, or metastatic carcinoma. However, there can be elevated levels of ALT with infectious mononucleosis, muscular dystrophy, and dermatomyositis. FDA UDI
Identifiers
- Catalog Number
- 501-399 FDA UDI
- Primary DI / UDI-DI
- 00812137011862 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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 (SGPT) Reagent Set by Clinical Diagnostic Solutions, Inc. — 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 — 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 (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 |
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Manufacturer
- Manufacturer
- Clinical Diagnostic Solutions, Inc.
Sources (1)
- FDA UDI 24bf1bae-a79b-4e6b-87ce-ae51f95206e5 36 fields · synced Jun 1, 2026