Xpert GBS GXGBS-100N-10

GUDID 07332940000127

Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)

Primary Device ID	07332940000127
NIH Device Record Key	495a09ce-7cd6-4433-887f-9ce579c2cae3
Commercial Distribution Status	In Commercial Distribution
Brand Name	Xpert GBS
Version Model Number	GXGBS-100N-10
Catalog Number	GXGBS-100N-10
Company DUNS	956711444
Company Name	CEPHEID
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Phone	1 888 838 3222
Email	techsupport@cepheid.com

Storage Environment Temperature

Between 2 Degrees Celsius and 28 Degrees Celsius

Device Issuing Agency	Device ID
GS1	07332940000127 [Primary]

NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Steralize Prior To Use	false
Device Is Sterile	false