QuickProfile™ Drugs of Abuse Test Cup 07RD7112-12

GUDID M90107RD7112120

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

LUMIQUICK DIAGNOSTICS, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device IDM90107RD7112120
NIH Device Record Keyd138f85b-10a8-4bcc-855f-bf7277d06dcf
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuickProfile™ Drugs of Abuse Test Cup
Version Model Number07RD7112-12
Catalog Number07RD7112-12
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

Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 Millimeter
Length74 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
HIBCCM90107RD7112120 [Primary]

FDA Product Code

DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-05-24
Device Publish Date2017-11-15

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

M90107RD7204040Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-
M90174046II0Immunoassay for the detection of the following drug substance(s) in human urine: Selection of
M90107RD7211010Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP
M90107RD7210110Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / CO
M90107RD7210060Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD
M90107RD721005A0Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP
M90107RD7210050Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP
M90107RD7210030Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD
M90107RD7210020Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP
M90107RD7208110Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZ
M90107RD7208100Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD
M90107RD7207170Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZ
M90107RD7207160Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / CO
M90107RD7207140Immunoassay for the detection of the following drug substance(s) in human urine: BAR / BUP / BZD
M90107RD7207100Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD
M90107RD7207020Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / CO
M90107RD7206110Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / CO
M90107RD7206090Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
M90107RD7206050Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / CO
M90107RD7206010Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
M90107RD7205090Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP
M90107RD7205080Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP /
M90107RD7205070Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OP
M90107RD7205021Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-
M90107RD7205010Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-
M90107RD7116130Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
M90107RD7116090Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-A
M90107RD7116080Immunoassay for the detection of the following drug substance(s) in human urine: BAR / BZD / BUP
M90107RD7116040Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD
M90107RD7116030Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP
M90107RD7116010Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP
M90107RD7113060Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD
M90107RD7113050Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC
M90107RD7113040Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
M90107RD7113030Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / COC
M90107RD7113020Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC
M90107RD7112150Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC
M90107RD7112130Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / CO
M90107RD7112120Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-A
M90107RD7112020Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
M90107RD7111310Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / O
M90107RD7111040Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-A
M90107RD7111030Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
M90107RD7111020Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / O
M90107RD7111010Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI
M90107RD7110220Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / O
M90107RD7110210Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
M90107RD7108020Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI
M90107RD7108010Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
M90107RD7205100Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / M-
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