Genomadix Cube CYP2C19

GUDID G257ASM001030

Oral/upper respiratory tract specimen collection swab IVD

Primary Device ID	G257ASM001030
NIH Device Record Key	303ffe6e-b495-4811-b367-3c06ef40b3da
Commercial Distribution Status	In Commercial Distribution
Brand Name	Genomadix Cube CYP2C19
Version Model Number	2
Company DUNS	204354752
Company Name	Genomadix Inc
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	false
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

Device Issuing Agency	Device ID
HIBCC	G257ASM001030 [Primary]

NTI	Drug Metabolizing Enzyme Genotyping Systems

Steralize Prior To Use	false
Device Is Sterile	false

G257ASM001160	Each unit is a box of 5 training kits (containing water).
G257ASM001030	Each unit is a box of 20 swabs.
G257ASM001010	Genomadix Cube CYP2C19 System, Test Kit, Cartridges: Contains substances for DNA extraction, PCR
G257ASM000990	Genomadix Cube CYP2C19 System, Control Kit, Cartridges. Box of 10 controls, reagents.
G257ASM000960	This contains the laptop, cube, power adapter and cables.