QuickProfile™ Drugs of Abuse Panel 5 Test 07RD7064-40

GUDID M90107RD7064401

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

Primary Device ID	M90107RD7064401
NIH Device Record Key	b9643fe7-0046-4d75-9c99-1d70aa7bf6b0
Commercial Distribution Status	In Commercial Distribution
Brand Name	QuickProfile™ Drugs of Abuse Panel 5 Test
Version Model Number	07RD7064-40
Catalog Number	07RD7064-40
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	M90107RD7064400 [Primary]
HIBCC	M90107RD7064401 [Package] Contains: M90107RD7064400 Package: PACK [25 Units] In Commercial Distribution

DJC	Thin Layer Chromatography, Methamphetamine

Steralize Prior To Use	false
Device Is Sterile	false

M90107RD706403A0	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
M90107RD7064401	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / M-AMP /
M90107RD7064391	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / CO
M90107RD706434A1	Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD
M90107RD7064341	Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD
M90107RD7064141	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD
M90107RD7064051	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
M90107RD7064041	Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC/ M-AM
M90107RD7064031	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
M90107RD7064021	Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / O
M90107RD7064011	Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI