Alinity m 08N53-002

GUDID 00884999048034

Alinity m System

ABBOTT MOLECULAR INC.

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 00884999048034
• NIH Device Record Key: f42c6bf2-c819-408a-8a37-1fdeab29ba2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alinity m
• Version Model Number: 08N53-002
• Catalog Number: 08N53-002
• Company DUNS: 878263359
• Company Name: ABBOTT MOLECULAR INC.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com
• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999048034 [Primary]

FDA Product Code

• OOI: real time Nucleic acid amplification system

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: 2020-08-26
• Device Publish Date: 2020-08-18

On-Brand Devices [Alinity m]

• 00884999048171: Alinity m IRU Waste Container
• 00884999048096: Alinity m Sample Rack Holder
• 20884999047864: Alinity m Integrated Reaction Unit (IRU)
• 20884999047857: Alinity m Pipette Tips, 1000uL
• 20884999047840: Allinity m Pipette Tips, 50uL
• 00884999047501: Alinity m CO-RE Tip Sleeve
• 00884999047488: Alinity m Pipette Tip Adapters
• 00884999047464: Alinity m Universal Sample Rack
• 00884999047457: Alinity m Handheld Barcode Scanner
• 00884999047440: Alinity m Assay Tray Carrier
• 00884999047433: Alinity m Waste Bottle
• 00884999047426: Alinity m Waste Box
• 00884999048652: Alinity m HCV Application Specification File
• 00884999047839: Alinity m HCV CTRL Kit
• 00884999047822: Alinity m HCV CAL Kit
• 00884999047761: Alinity m HCV AMP Kit
• 00884999049222: Alinity m SARS-CoV-2 AMP Kit
• 00884999049208: Alinity m SARS-CoV-2 CTRL Kit
• 00884999049185: Alinity m SARS-CoV-2 Application Specification File
• 20884999047901: Alinity m Diluent Solution Kit
• 00884999047716: Alinity m Vapor Barrier Solution
• 00884999048034: Alinity m System
• 00884999047730: 08N45-095
• 00884999048638: Alinity m HIV-1 Application Specification File
• 00884999047785: 08N45-085
• 00884999047778: 08N45-075
• 00884999048645: Alinity m HBV Application Specification File
• 00884999047815: Alinity m HBV CTRL Kit
• 00884999047808: Alinity m HBV CAL Kit
• 00884999047754: Alinity m HBV AMP Kit
• 00884999049413: Alinity m Resp-4-Plex Application Specification File
• 00884999049406: Alinity m Resp-4-Plex CTRL Kit
• 00884999049390: Alinity m Resp-4-Plex AMP Kit
• 00884999050020: 1.00
• 00884999050136: Alinity m SARS COV-2 Application Specification File
• 00884999050211: Alinity m SARS-CoV-2 Application Specification
• 00884999047877: Alinity m Lysis Solution
• 00884999047679: Alinity m Sample Prep Kit 2
• 00884999049314: Alinity m Bottle for Ethanol Use
• 30884999050410: 09N19-012
• 00884999047693: Alinity m Ethanol Solution
• 00884999047686: Alinity m Sample Prep Kit 1
• 00884999050280: Abbott Bulk Universal Collection Kit
• 00884999049956: Alinity m CMV Application Specification File
• 00884999049611: Alinity m CMV AMP Kit
• 00884999049604: Alinity m CMV CTRL Kit
• 00884999049598: Alinity m CMV CAL Kit
• 00884999048669: Alinity m STI Application Specification File
• 00884999048607: Alinity m STI CTRL Kit
• 00884999048591: Alinity m STI AMP Kit