Identity
- Trade Name
- Alere Afinion ACR Control FDA UDI
- Generic Name
- Microalbumin IVD, control FDA UDI
- Device Name
- ACR Control for use with the Alere Afinion ACR test and Afinion ACR test. Contents: 1 Control C I, 1 Control C II, 1 package insert. DI covers Alere Afinion ACR Control and and Afinion ACR Control. FDA UDI
- Model / Reference
- 1115239 FDA UDI
- Description
- ACR Control for use with the Alere Afinion ACR test and Afinion ACR test. Contents: 1 Control C I, 1 Control C II, 1 package insert. DI covers Alere Afinion ACR Control and and Afinion ACR Control. FDA UDI
Identifiers
- Catalog Number
- 1115239 FDA UDI
- Primary DI / UDI-DI
- 07070060006765 FDA UDI
- GMDN Term
- Microalbumin IVD, control FDA UDI
Classification
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: Microalbumin IVD, control
Alere Afinion ACR Control by Abbott Diagnostics Technologies AS — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Abbott Diagnostics Technologies AS
Sources (1)
- FDA UDI 92fff2da-1308-452c-94f7-415ab56c9814 35 fields · synced May 30, 2026