Xpert Vaginal/Endocervical Specimen Collection Kit SWAB/A-50

GUDID 07332940002558

Xpert Vaginal/Endocervical Specimen Collection Kit; 50 pack

CEPHEID

Urogenital specimen transport medium collection kit
Primary Device ID07332940002558
NIH Device Record Key1b17e25a-ea50-4bce-9f62-8d2d61cb7e42
Commercial Distribution StatusIn Commercial Distribution
Brand NameXpert Vaginal/Endocervical Specimen Collection Kit
Version Model NumberSWAB/A-50
Catalog NumberSWAB/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
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
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
GS107332940002558 [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

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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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