ViroSeq

Basic Information

• Brand Name: ViroSeq
• Primary DI: 00884999007475
• Version / Model: 4J94-93
• Catalog Number: 4J94-93
• Company Name: ABBOTT MOLECULAR INC.
• Labeler DUNS: 878263359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 930efbb1-ffaa-4965-a6b5-4c02b52d0e8a

Device Description

ViroSeq HIV-1 Genotyping System v2.0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHS	Assay, genotype, hiv drug resistance, in vitro	Immunology	866.3950	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48468	HIV1 genotyping IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to determine the genotype of human immunodeficiency virus 1 (HIV1) in a clinical specimen, using a nucleic acid technique (NAT). The genotyping is typically performed to help determine viral resistance to specific antiretroviral drugs (AVRs) during patient treatment planning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884999007475	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – -15 Degrees Celsius