ViroSeq 4J94-92

GUDID 00884999007468

Sequencing Consumables Kit

ABBOTT MOLECULAR INC.

Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD Microplate IVD

• Primary Device ID: 00884999007468
• NIH Device Record Key: 6fe93742-709b-4d2c-b524-82c565d520ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViroSeq
• Version Model Number: 4J94-92
• Catalog Number: 4J94-92
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999007468 [Primary]

FDA Product Code

• PPM: General purpose reagent

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-03
• Device Publish Date: 2017-02-20

On-Brand Devices [ViroSeq]

• 00884999039278: ViroSeq HIV-1 Genotyping Software v3.0 & Algorithm Advisor
• 00884999007475: ViroSeq HIV-1 Genotyping System v2.0
• 00884999007468: Sequencing Consumables Kit
• 00884999007420: PCR Cleanup Kit