Identity
- Trade Name
- ABX PENTRA LDH IFCC CP FDA UDI
- Generic Name
- Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- 1220001871 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005576 FDA UDI
- FDA Product Code
- CFJ FDA UDI
- GMDN Term
- Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1440 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: Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
Abx Pentra Ldh Ifcc Cp by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Alinity — Abbott · Class II
- LDH-L SL — VITALSCIENTIFIC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Horiba Abx
Sources (1)
- FDA UDI eec67570-99f1-47fa-98e0-f11b1f0cfc74 32 fields · synced May 29, 2026