Alinity mp 09N65-001

GUDID 00884999048911

Alinity mp System

ABBOTT MOLECULAR INC.

Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD Nucleic acid sample preparation instrument IVD

• Primary Device ID: 00884999048911
• NIH Device Record Key: ea65fc36-c4a2-4ba0-9cbd-a369a4a19df6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alinity mp
• Version Model Number: 09N65-001
• Catalog Number: 09N65-001
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999048911 [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: 2024-02-27
• Device Publish Date: 2024-02-19

Devices Manufactured by ABBOTT MOLECULAR INC.

• 00884999048911 - Alinity mp: 2024-02-27Alinity mp System
• 00884999048911 - Alinity mp: 2024-02-27 Alinity mp System
• 00884999051300 - Alinity m: 2024-02-08 Alinity m EBV Application Specification File
• 00884999048614 - Alinity m: 2024-01-10 Alinity m HR HPV AMP Kit
• 00884999048621 - Alinity m: 2024-01-10 Alinity m HR HPV CTRL Kit
• 00884999048676 - Alinity m: 2024-01-10 Alinity m HR HPV Application Specification File
• 00884999046757 - RealTime: 2023-10-09 Abbott RealTime ZIKA Control Kit
• 00884999046771 - RealTime: 2023-10-09 Abbott RealTime ZIKA Amplification Reagent Kit
• 00884999047068 - RealTime: 2023-10-09 Abbott RealTime ZIKA Application CD-ROM