Afinion™ 2 1116970

GUDID 07070060014616

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

Abbott Diagnostics Technologies AS

Multiple clinical chemistry analyser IVD, point-of-care
Primary Device ID07070060014616
NIH Device Record Keyeedbb437-3c9a-443e-ae51-d3363012aab6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAfinion™ 2
Version Model Number1116970
Catalog Number1116970
Company DUNS515324122
Company NameAbbott Diagnostics Technologies AS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107070060014616 [Primary]

FDA Product Code

JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-03
Device Publish Date2023-10-26

On-Brand Devices [Afinion™ 2]

07070060014708Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient test
07070060014692Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient test
07070060014623Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient test
07070060014616Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient test

Trademark Results [Afinion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFINION
AFINION
76544018 2991061 Live/Registered
ALERE TECHNOLOGIES AS
2003-09-11

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