Who else makes this device?

Name: Afinion™ 2
Brand: Afinion™ 2

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

Afinion™ 2

Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient testing and laboratory use. Afinion 2 is designed for use with the Afinion Test Cartridges only.…

Registry build 21.09.26

Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient testing and laboratory use. Afinion 2 is designed for use with the Afinion Test Cartridges only. The Afinion 2 System, consisting of Afinion 2 Analyzer with Afinion Test Cartridges and Afinion Controls, is intended for in vitro diagnostic use only. Contents: 1 Afinion 2 Analyzer

1manufacturer

4catalogue numbers in this listing

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 Afinion™ 2
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
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	Storage environment temperature -29 to 60 °C; Storage environment humidity 10 to 95 % RH; Handling environment temperature 15 to 32 °C

Catalogue Numbers

Catalogue numbers for Afinion™ 2
Catalogue number	Size	Status
1116985		In distribution
1116970		In distribution
1116971		In distribution
1116986		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
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
Alere Afinion™ AS100	Abbott Diagnostics Technologies AS	1

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Afinion™ 2
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Abbott Diagnostics Technologies AS	UDI-DI	2024-06-17	Class II	Reprocessing Controls	Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.	5 analyzers

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.