Respiratory Virus Plus (RV+) Extraction Tray

GUDID 00857573006232

The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.

NANOSPHERE, INC.

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00857573006232
NIH Device Record Keybd09779b-5fe0-486d-b56d-c598118d80a5
Commercial Distribution Discontinuation2019-08-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRespiratory Virus Plus (RV+) Extraction Tray
Version Model Number20-009-020
Company DUNS164757242
Company NameNANOSPHERE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone888-837-4436
Emailproductsupport@nanosphere.us

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857573006232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCCRespiratory Virus Panel Nucleic Acid Assay System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-22
Device Publish Date2016-09-23

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