QuickProfile™ Drugs of Abuse Panel 5 Test 07RD7064-34

GUDID M90107RD7064341

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

LUMIQUICK DIAGNOSTICS, INC.

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Primary Device IDM90107RD7064341
NIH Device Record Keydd297758-1486-4c73-890f-992d9f8d8264
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuickProfile™ Drugs of Abuse Panel 5 Test
Version Model Number07RD7064-34
Catalog Number07RD7064-34
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
HIBCCM90107RD7064340 [Primary]
HIBCCM90107RD7064341 [Package]
Contains: M90107RD7064340
Package: PACK [25 Units]
In Commercial Distribution

FDA Product Code

DJREnzyme Immunoassay, Methadone

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 5 Test]

M90107RD706403A0Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
M90107RD7064401Immunoassay for the detection of the following drug substance(s) in human urine: AMP / M-AMP /
M90107RD7064391Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / CO
M90107RD706434A1Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD
M90107RD7064341Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD
M90107RD7064141Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD
M90107RD7064051Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
M90107RD7064041Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC/ M-AM
M90107RD7064031Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
M90107RD7064021Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / O
M90107RD7064011Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI
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