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 ID00884999007475
NIH Device Record Key930efbb1-ffaa-4965-a6b5-4c02b52d0e8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameViroSeq
Version Model Number4J94-93
Catalog Number4J94-93
Company DUNS878263359
Company NameABBOTT MOLECULAR INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)553-7042
Emailcustomerservice@abbottmolecular.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100884999007475 [Primary]

FDA Product Code

NHSAssay, genotype, hiv drug resistance, in vitro

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-10

On-Brand Devices [ViroSeq]

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

Trademark Results [ViroSeq]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VIROSEQ
VIROSEQ
85756611 4438690 Live/Registered
ABBOTT MOLECULAR INC.
2012-10-17
VIROSEQ
VIROSEQ
77531059 3769806 Live/Registered
ABBOTT MOLECULAR INC.
2008-07-24
VIROSEQ
VIROSEQ
77531056 3765927 Live/Registered
ABBOTT MOLECULAR INC.
2008-07-24
VIROSEQ
VIROSEQ
75779439 2520852 Live/Registered
ABBOTT MOLECULAR INC.
1999-08-19
VIROSEQ
VIROSEQ
75779437 not registered Dead/Abandoned
Perkin-Elmer Corporation, The
1999-08-19

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