Xpert BCR-ABL Ultra GXBCRABL-US-10

GUDID 07332940007102

Philadelphia chromosome/BCR-ABL transcript IVD, kit, nucleic acid technique (NAT)

Primary Device ID	07332940007102
NIH Device Record Key	5b24dea1-190d-4e6c-87a4-6dd2c5474875
Commercial Distribution Status	In Commercial Distribution
Brand Name	Xpert BCR-ABL Ultra
Version Model Number	GXBCRABL-US-10
Catalog Number	GXBCRABL-US-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

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	07332940007102 [Primary]

OYX	Bcr/Abl1 Monitoring Test

Steralize Prior To Use	false
Device Is Sterile	false