Xpert Check XPERTCHECK-US-5

GUDID 07332940001872

PCR instrument calibrator kit IVD

Primary Device ID	07332940001872
NIH Device Record Key	d2c4c911-e831-4c4b-8614-720742e20987
Commercial Distribution Status	In Commercial Distribution
Brand Name	Xpert Check
Version Model Number	XPERTCHECK-US-5
Catalog Number	XPERTCHECK-US-5
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	false
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

Device Issuing Agency	Device ID
GS1	07332940001872 [Primary]

OHQ	Multi-Analyte Controls Unassayed

Steralize Prior To Use	false
Device Is Sterile	false