Identity
- Trade Name
- Eurotrol AlbuTrol FDA UDI
- Generic Name
- Albumin IVD, control FDA UDI
- Device Name
- Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin. FDA UDI
- Model / Reference
- AlbuTrol Level 2 FDA UDI
- Description
- Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin. FDA UDI
Identifiers
- Catalog Number
- 189.002.002 FDA UDI
- Primary DI / UDI-DI
- 08718734960645 FDA UDI
- 510(k) Number
- K060215 FDA UDI
- FDA Product Code
- JJX 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
No
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
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
Eurotrol AlbuTrol by Eurotrol B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Albumin IVD, control.
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- Optilite® Low Level Albumin Control Pack — The Binding Site Group · Class I
- IMMULITE® Systems ALB CONTROL Albumin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Autokit Micro Albumin Control Set — FUJIFILM WAKO PURE CHEMICAL CORPORATION · Class I
- Diazyme — Diazyme Laboratories, Inc.
Cleared under the same submission
K060215 also covers:
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
- Eurotrol B.V.
Sources (1)
- FDA UDI 697bb490-77fd-4985-8bc8-34cb1f0b7647 35 fields · synced Jun 6, 2026