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Alanine aminotransferase acc. IFCC with or without PYP
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Alanine aminotransferase acc. IFCC with or without PYP FDA UDI
- Generic Name
- Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry FDA UDI
- Model / Reference
- 4718569190 FDA UDI
Identifiers
- Catalog Number
- 4718569190 FDA UDI
- Primary DI / UDI-DI
- 04015630921973 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
Alanine aminotransferase acc. IFCC with or without PYP by Roche Diagnostics Corp. — 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 (ALT) — Randox Laboratories, Ltd. · 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
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI a63508ae-5f3a-43a8-ac0a-f637c27989df 33 fields · synced May 30, 2026