Xpert Urine Specimen Collection Kit URINE/A-50

GUDID 07332940002954

Xpert Urine Specimen Collection Kit; 50 pack

CEPHEID

Sexually transmitted infection (STI) testing urine specimen collection kit IVD
Primary Device ID07332940002954
NIH Device Record Key00dcc782-9353-4928-a7be-a21e19eaece8
Commercial Distribution StatusIn Commercial Distribution
Brand NameXpert Urine Specimen Collection Kit
Version Model NumberURINE/A-50
Catalog NumberURINE/A-50
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

Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com
Phone18888383222
Emailtechsupport@cepheid.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107332940002954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIODevice, Specimen Collection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-02
Device Publish Date2018-07-02

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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