xTAG® RVP FAST (Respiratory Viral Panel Fast) I025C0197

GUDID 00840487100486

The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections

Luminex Molecular Diagnostics, Inc

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00840487100486
NIH Device Record Key71ef1470-7cf2-4118-927f-92cd3267a95e
Commercial Distribution Discontinuation2020-01-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NamexTAG® RVP FAST (Respiratory Viral Panel Fast)
Version Model NumberI025C0197
Catalog NumberI025C0197
Company DUNS255371916
Company NameLuminex Molecular Diagnostics, 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 Usefalse
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(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone+1(877)785-2323
Emailsupport@luminexcorp.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840487100486 [Primary]

FDA Product Code

OEMHuman metapneumovirus (hmpv) rna assay system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-01-03
Device Publish Date2016-09-09

Devices Manufactured by Luminex Molecular Diagnostics, Inc

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00840487100417 - NxTAG® Respiratory Pathogen Panel2020-01-03 The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simul
00840487100462 - xTAG® RVP (Respiratory Viral Panel)2020-01-03 The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection an
00840487100486 - xTAG® RVP FAST (Respiratory Viral Panel Fast)2020-01-03The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections
00840487100486 - xTAG® RVP FAST (Respiratory Viral Panel Fast)2020-01-03 The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous de
00840487100493 - xTAG® Gastrointestinal Pathogen Panel (GPP)2019-11-26 The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and ide
00840487100141 - xTAG® Cystic Fibrosis (CFTR) 39 kit v22019-10-28 The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in
00840487100134 - xTAG® CYP2D6 Kit v32018-07-06 The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the
00840487100172 - xTAG® CYP2C19 Kit v32018-07-06 The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide varian

Trademark Results [xTAG]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XTAG
XTAG
88416429 not registered Live/Pending
Guangzhou Huaju Information Technology Co., Ltd.
2019-05-06
XTAG
XTAG
88023855 not registered Live/Pending
Seeonic, Inc.
2018-07-02
XTAG
XTAG
86770178 5033131 Live/Registered
Mobex, Inc.
2015-09-28
XTAG
XTAG
85187358 4025320 Dead/Cancelled
Alternatives Technologie Pharma Inc.
2010-11-30
XTAG
XTAG
79095998 4017961 Dead/Cancelled
XAVIER MUÑOZ BELLVEHÍ
2010-11-12

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