ViroSeq 4J94-93

GUDID 00884999007475

ViroSeq HIV-1 Genotyping System v2.0

ABBOTT MOLECULAR INC.

HIV1 genotyping IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00884999007475
• NIH Device Record Key: 930efbb1-ffaa-4965-a6b5-4c02b52d0e8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViroSeq
• Version Model Number: 4J94-93
• Catalog Number: 4J94-93
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999007475 [Primary]

FDA Product Code

• NHS: Assay, genotype, hiv drug resistance, in vitro

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-10

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