Alinity mp 09N65-007

GUDID 00884999048973

Alinity mp Reagent Addition Assembly

ABBOTT MOLECULAR INC.

Instrument/analyser specimen/reagent container carrier IVD

• Primary Device ID: 00884999048973
• NIH Device Record Key: a5474599-2220-417a-a77a-84a47061c2f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alinity mp
• Version Model Number: 09N65-007
• Catalog Number: 09N65-007
• Company DUNS: 878263359
• Company Name: ABBOTT MOLECULAR INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Ambient (15-30C)
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999048973 [Primary]

FDA Product Code

• JQW: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

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: 2025-06-05
• Device Publish Date: 2025-05-28

On-Brand Devices [Alinity mp]

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• 00884999048980: 09N65-008
• 00884999048959: Alinity mp SurePath Holder, Replacement
• 00884999048942: Alinity mp Exception Rack, Replacement
• 00884999048935: Alinity mp Vial Input Rack Replacement
• 00884999048928: 09N65-002
• 00884999051720: Alinity mp Well Plate
• 00884999051515: Alinity mp Well Plate Input Rack
• 00884999051508: Alinity mp Tube Input Rack
• 00884999048973: Alinity mp Reagent Addition Assembly