Xpert Norovirus GXNOV-10

GUDID 07332940000974

Xpert Norovirus kit; 10 test kit

CEPHEID

Multiple gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID07332940000974
NIH Device Record Key57c9e56e-aedf-469a-9f1a-b59256bfd3b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameXpert Norovirus
Version Model NumberGXNOV-10
Catalog NumberGXNOV-10
Company DUNS956711444
Company NameCEPHEID
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

Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.com
Phone1 888 838 3222
Emailtechsupport@cepheid.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

Device Identifiers

Device Issuing AgencyDevice ID
GS107332940000974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PCHGastrointestinal Pathogen 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 Number3
Public Version Date2018-07-06
Device Publish Date2018-01-29

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