GenaCheck™ Fentanyl Urine Home-Use Test Cassette

GUDID 00860008954800

Multiple drugs of abuse IVD, control

Primary Device ID	00860008954800
NIH Device Record Key	b7904151-c7f5-43b8-b4af-484b8a7d81f0
Commercial Distribution Status	In Commercial Distribution
Brand Name	GenaCheck™ Fentanyl Urine Home-Use Test Cassette
Version Model Number	RA9-E02525
Company DUNS	118586095
Company Name	Genabio Diagnostics 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	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	true
RX Perscription	false
OTC Over-The-Counter	true

Device Issuing Agency	Device ID
GS1	00860008954800 [Primary]
GS1	10860008954807 [Package] Package: Carton [108 Units] In Commercial Distribution

NGL	Test, Opiates, Over The Counter

Steralize Prior To Use	false
Device Is Sterile	false

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Mark Image Registration \| Serial	Company Trademark Application Date
GENACHECK 97927680 not registered Live/Pending	Genabio Diagnostics Inc. 2023-05-09