ViroSeq HIV
ViroSeq - 4J94-93
Device Description
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.
Environmental Conditions
- -15.00
- -25.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NHS
Device Name: Assay, Genotype, Hiv Drug Resistance, In Vitro
Device Class: 2
Physical State: N/A
Definition: Hiv-1 drug resistance genotyping
Submission Type ID: 1
Review Panel: IM
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.3950
Third Party Flag: N
Medical Specialty: IM
Device IdentifiersDevice Id: 00884999007475
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A