Enteric Pathogens (EP) Nucleic Acid Test Cartridge

GUDID 00857573006041

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.

NANOSPHERE, INC.

Multiple gastrointestinal pathogen nucleic acid IVD, kit, microarray
Primary Device ID00857573006041
NIH Device Record Key915202b3-ef4f-4f56-9156-5f6d9fade8f9
Commercial Distribution Discontinuation2019-12-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEnteric Pathogens (EP) Nucleic Acid Test Cartridge
Version Model Number20-006-023
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
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com
Phone888-837-4436
Emailproductsupport@nanosphere.us
Phone+1(877)785-2323
Emailsupport@luminexcorp.com

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840487101520 [Primary]
GS100857573006041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PCHGastrointestinal pathogen panel multiplex nucleic acid-based assay system
PCIGastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-06
Device Publish Date2016-09-23

Devices Manufactured by NANOSPHERE, INC.

00857573006003 - Verigene® Reader 2019-12-06 The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilize
00857573006010 - Verigene® Processor SP 2019-12-06 The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization
00857573006027 - Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge2019-12-06 The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucle
00857573006041 - Enteric Pathogens (EP) Nucleic Acid Test Cartridge2019-12-06The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
00857573006041 - Enteric Pathogens (EP) Nucleic Acid Test Cartridge2019-12-06 The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identi
00857573006058 - Enteric Pathogens (EP) Extraction Tray2019-12-06 The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and iden
00857573006065 - Enteric Pathogens (EP) Stool Sample Preparation Kit2019-12-06 The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and iden
00857573006089 - Enteric Pathogens (EP) Amplification Tray2019-12-06 The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and iden
00857573006119 - Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge2019-12-06 The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System i
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.