ViroSeq 4J94-23

GUDID 00884999039278

ViroSeq HIV-1 Genotyping Software v3.0 & Algorithm Advisor

ABBOTT MOLECULAR INC.

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD

• Primary Device ID: 00884999039278
• NIH Device Record Key: 9ce3c0de-661f-4109-a64a-3abedb386815
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViroSeq
• Version Model Number: 4J94-23
• Catalog Number: 4J94-23
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999039278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK130039

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-06

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