Xpert MRSA NxG GXMRSA-NXG-120

GUDID 07332940001728

MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)

Primary Device ID	07332940001728
NIH Device Record Key	e3c2bfad-7fa9-4498-b0d4-0e108d3ad0f2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Xpert MRSA NxG
Version Model Number	GXMRSA-NXG-120
Catalog Number	GXMRSA-NXG-120
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

Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 28 Degrees Celsius

Device Issuing Agency	Device ID
GS1	07332940001728 [Primary]

NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

Steralize Prior To Use	false
Device Is Sterile	false

07332940001728	Xpert MRSA NxG kit: 120 test kit
07332940001711	Xpert MRSA NxG kit; 10 test kit