QuickProfile™ Drugs of Abuse Panel 2 Test 07RD7061-02A

GUDID M90107RD706102A1

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

Primary Device ID	M90107RD706102A1
NIH Device Record Key	6366fabe-5c66-4287-8f98-172bf430576f
Commercial Distribution Status	In Commercial Distribution
Brand Name	QuickProfile™ Drugs of Abuse Panel 2 Test
Version Model Number	07RD7061-02A
Catalog Number	07RD7061-02A
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	M90107RD706102A0 [Primary]
HIBCC	M90107RD706102A1 [Package] Contains: M90107RD706102A0 Package: PACK [25 Units] In Commercial Distribution

DJG	Enzyme Immunoassay, Opiates

Steralize Prior To Use	false
Device Is Sterile	false

M90107RD706104A1	Immunoassay for the detection of the following drug substance(s) in human urine: BZD / OPI-2000
M90107RD7061031	Immunoassay for the detection of the following drug substance(s) in human urine: MAMP / THC
M90107RD706102A1	Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI-200
M90107RD7061011	Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC