Xpert FLU/RSV XC GXFLU/RSV-10

GUDID 07332940000783

Xpert FLU/RSV XC kit; 10 test kit

CEPHEID

Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID07332940000783
NIH Device Record Key03e6b4f0-26d8-4293-b21e-daab64dcd559
Commercial Distribution StatusIn Commercial Distribution
Brand NameXpert FLU/RSV XC
Version Model NumberGXFLU/RSV-10
Catalog NumberGXFLU/RSV-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
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 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107332940000783 [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 Number3
Public Version Date2018-07-06
Device Publish Date2018-01-29

Devices Manufactured by CEPHEID

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07332940008161 - GeneXpert®2024-02-26 Xpert® Xpress GBS
07332940008581 - GeneXpert®2024-01-30 Xpert® Xpress CoV-2 plus
07332940009243 - GeneXpert® Xpress2023-10-30 GENEXPERT Xpress System
07332940008604 - GeneXpert®2023-10-03 Xpert Xpress CoV-2/Flu/RSV plus
07332940007652 - Xpert®2022-08-08 GBS LB XC
07332940007669 - Xpert®2022-08-08 GBS LB XC
07332940007195 - GeneXpert®2022-05-20 Xpress System
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