Identity
- Trade Name
- ALT/SGPT Liqui-UV® FDA UDI
- Generic Name
- Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- For the Kinetic Quantitative Determination of ALT/ GPT in Serum for Manual and/or Automated Procedures. FDA UDI
- Model / Reference
- 2930-500 FDA UDI
- Description
- For the Kinetic Quantitative Determination of ALT/ GPT in Serum for Manual and/or Automated Procedures. FDA UDI
Identifiers
- Catalog Number
- 2930-500 FDA UDI
- Primary DI / UDI-DI
- 00657498000472 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
No
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, kit, enzyme spectrophotometry
ALT/SGPT Liqui-UV® by Stanbio Laboratory, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry.
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- 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
- POINTE SCIENTIFIC ALT — 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
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 8843a343-cbdf-4c3e-a2e8-49bb512ff687 36 fields · synced May 30, 2026