QuickProfile™ Amphetamine Test Card 07RD7014

GUDID M90107RD70141

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	M90107RD70141
NIH Device Record Key	fd7f6484-9915-4606-8539-e490dcebea47
Commercial Distribution Status	In Commercial Distribution
Brand Name	QuickProfile™ Amphetamine Test Card
Version Model Number	07RD7014
Catalog Number	07RD7014
Company DUNS	790175165
Company Name	LUMIQUICK 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	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

Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 4 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	M90107RD70140 [Primary]
HIBCC	M90107RD70141 [Package] Contains: M90107RD70140 Package: PACK [25 Units] In Commercial Distribution

DKZ	Enzyme Immunoassay, Amphetamine

Steralize Prior To Use	false
Device Is Sterile	false

M90174014	Immunoassay for the detection of amphetamine in human urine
M90107RD70141	Immunoassay for the detection of amphetamine in human urine