Identity
- Trade Name
- ABX PENTRA ALT CP FDA UDI
- Generic Name
- Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry FDA UDI
- Model / Reference
- 1220001627 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230004906 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
No
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
Abx Pentra Alt Cp by Horiba Abx — 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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- 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
- Horiba Abx
Sources (1)
- FDA UDI 8355d28a-a411-4b80-b3e1-64992aa2c47d 32 fields · synced Jun 1, 2026