Identity
- Trade Name
- ABX PENTRA MICRO-ALB CAL FDA UDI
- Generic Name
- Albumin IVD, calibrator FDA UDI
- Model / Reference
- 1220001966 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005774 FDA UDI
- FDA Product Code
- DCF FDA UDI
- GMDN Term
- Albumin IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5040 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: Albumin IVD, calibrator
Abx Pentra Micro-Alb Cal by Horiba Abx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 dba429ec-bdb3-408b-8d67-ccca5b07606b 32 fields · synced May 29, 2026