QuickProfile™ Drugs of Abuse Panel 7 Test 07RD7070-15

GUDID M90107RD7070151

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

LUMIQUICK DIAGNOSTICS, INC.

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Primary Device IDM90107RD7070151
NIH Device Record Key3eb48c80-076f-4905-bd00-8c97c086d6de
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuickProfile™ Drugs of Abuse Panel 7 Test
Version Model Number07RD7070-15
Catalog Number07RD7070-15
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
HIBCCM90107RD7070150 [Primary]
HIBCCM90107RD7070151 [Package]
Contains: M90107RD7070150
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 Number3
Public Version Date2021-05-24
Device Publish Date2017-11-15

On-Brand Devices [QuickProfile™ Drugs of Abuse Panel 7 Test]

M90107RD7070191Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC
M90107RD7070181Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD
M90107RD7070171Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
M90107RD7070151Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC
M90107RD7070141Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD
M90107RD7070131Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD
M90107RD7070121Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD
M90107RD7070111Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / CO
M90107RD7070041Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD
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