QuickProfile™ Drugs of Abuse Panel 6 Test 07RD7065-43

GUDID M90107RD7065430

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

Primary Device ID	M90107RD7065430
NIH Device Record Key	fe4a19b6-806a-4125-84fc-b6672e79ef82
Commercial Distribution Status	In Commercial Distribution
Brand Name	QuickProfile™ Drugs of Abuse Panel 6 Test
Version Model Number	07RD7065-43
Catalog Number	07RD7065-43
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	M90107RD7065430 [Primary]
HIBCC	M90107RD7065431 [Package] Package: PACK [25 Units] In Commercial Distribution

DJC	Thin Layer Chromatography, Methamphetamine

Steralize Prior To Use	false
Device Is Sterile	false

M90107RD7065430	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-
M90107RD7065421	Immunoassay for the detection of the following drug substance(s) in human urine: AMP/ BZD / M-AM
M90107RD7065401	Immunoassay for the detection of the following drug substance(s) in human urine: BUP / COC / M-A
M90107RD7065391	Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-A
M90107RD7065321	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
M90107RD7065311	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC
M90107RD7065281	Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-A
M90107RD7065231	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
M90107RD7065151	Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC
M90107RD7065061	Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC
M90107RD7065021	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
M90107RD7065011	Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-A
M09107RD7065221	Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC