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

GUDID M90107RD7065430

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / OPI / OXY / THC

LUMIQUICK DIAGNOSTICS, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device IDM90107RD7065430
NIH Device Record Keyfe4a19b6-806a-4125-84fc-b6672e79ef82
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuickProfile™ Drugs of Abuse Panel 6 Test
Version Model Number07RD7065-43
Catalog Number07RD7065-43
Company DUNS790175165
Company NameLUMIQUICK DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com
Phone1-408-855-0061
Emailudi@lumiquick.com

Device Dimensions

Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM90107RD7065430 [Primary]
HIBCCM90107RD7065431 [Package]
Package: PACK [25 Units]
In Commercial Distribution

FDA Product Code

DJCThin Layer Chromatography, Methamphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-05-24
Device Publish Date2019-09-24

On-Brand Devices [QuickProfile™ Drugs of Abuse Panel 6 Test]

M90107RD7065430Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-
M90107RD7065421Immunoassay for the detection of the following drug substance(s) in human urine: AMP/ BZD / M-AM
M90107RD7065401Immunoassay for the detection of the following drug substance(s) in human urine: BUP / COC / M-A
M90107RD7065391Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-A
M90107RD7065321Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
M90107RD7065311Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC
M90107RD7065281Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-A
M90107RD7065231Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
M90107RD7065151Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC
M90107RD7065061Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC
M90107RD7065021Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
M90107RD7065011Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-A
M09107RD7065221Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.