Identity
- Trade Name
- ABX PENTRA MICRO ALB CONTROL L/H FDA UDI
- Generic Name
- Albumin IVD, control FDA UDI
- Model / Reference
- 1220001967 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005781 FDA UDI
- 510(k) Number
- K133676 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Albumin IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
No
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, control
Abx Pentra Micro Alb Control L/H by Horiba Abx — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Eurotrol AlbuTrol — Eurotrol B.V. · Class I
- Autokit Micro Albumin Control Set — FUJIFILM WAKO PURE CHEMICAL CORPORATION · 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 2230632a-a960-4728-9f2d-82f0c5b4b71c 33 fields · synced May 31, 2026