Afinion™ 2 1116971

GUDID 07070060014623

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 ID: 07070060014623
• NIH Device Record Key: b6732953-814a-441c-92cd-0a37770450ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Afinion™ 2
• Version Model Number: 1116971
• Catalog Number: 1116971
• Company DUNS: 515324122
• Company Name: Abbott Diagnostics Technologies AS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07070060014623 [Primary]

FDA Product Code

• JQT: Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-03
• Device Publish Date: 2023-10-26

On-Brand Devices [Afinion™ 2]

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