Identity
- Trade Name
- Alere Afinion™ AS100 FDA UDI
- Generic Name
- Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
- Device Name
- Alere Afinion AS100 Analyzer with Alere Afinion Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of care testing, designed to analyze the Afinion Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion Analyzer to a laboratory information system or another electronic journal system. Alere Afinion AS100 Analyzer System, consisting of Alere Afinion AS100 Analyzer with Alere Afinion Data Connectivity Converter (ADCC), Afinion Test Cartridges and Afinion Controls is for in vitro diagnostic use only. Contents: 1 Alere Afinion AS100 FDA UDI
- Model / Reference
- 1115390 FDA UDI
- Description
- Alere Afinion AS100 Analyzer with Alere Afinion Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of care testing, designed to analyze the Afinion Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion Analyzer to a laboratory information system or another electronic journal system. Alere Afinion AS100 Analyzer System, consisting of Alere Afinion AS100 Analyzer with Alere Afinion Data Connectivity Converter (ADCC), Afinion Test Cartridges and Afinion Controls is for in vitro diagnostic use only. Contents: 1 Alere Afinion AS100 FDA UDI
Identifiers
- Catalog Number
- 1115390 FDA UDI
- Primary DI / UDI-DI
- 07070060008042 FDA UDI
- 510(k) Number
- K151809 FDA UDI
- FDA Product Code
- JQT FDA UDI
- GMDN Term
- Multiple clinical chemistry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2400 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple clinical chemistry analyser IVD, point-of-care
Alere Afinion™ AS100 by Abbott Diagnostics Technologies AS — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Abbott Diagnostics Technologies AS
Sources (1)
- FDA UDI 183b0ed5-f41a-40ce-b7be-c1d1ebe56d25 36 fields · synced May 30, 2026