Who else makes this device?

Name: Alere Afinion™ AS100
Brand: Alere Afinion™ AS100

Clinical Chemistry › Laboratory InstrumentsDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

Alere Afinion™ AS100

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…

Registry build 21.09.26

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

1manufacturer

1catalogue number

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code JQT
Manufacturer	City	Province	Registered as	Device types
Infitek Co., Ltd.	Shanghai	Shanghai	Manufacturer	49

Record

Regulatory record for Alere Afinion™ AS100
Listed by	Abbott Diagnostics Technologies AS, Norway
FDA product code	JQT
Device type	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device class	Class 1
Regulation	21 CFR 862.2400
Establishment	Manufacturer
510(k)	K151809
Record published	2023-10-26

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, manufacturing date
Storage	Handling environment temperature 15 to 32 °C; Storage environment temperature -40 to 70 °C

Catalogue Numbers

Catalogue numbers for Alere Afinion™ AS100
Catalogue number	Size	Status
1115390		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Afinion™ 2	Abbott Diagnostics Technologies AS	4
ViraChip Scanner	Viramed Biotech AG	1
ViraChip Reader	Viramed Biotech AG	1
EUROLineScan	Euroimmun Medizinische Labordiagnostika AG	1
ASiManager-AT	Arlington Scientific, Inc.	1
Nano-CheckerTM 710 Reader	Nano-Ditech Corporation	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.