QuickProfile™ Amphetamine Test Card 74014

GUDID M90174014

Immunoassay for the detection of amphetamine in human urine

LUMIQUICK DIAGNOSTICS, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device IDM90174014
NIH Device Record Keyc13e4ef0-efb4-470e-ba3b-09a6b64e615a
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuickProfile™ Amphetamine Test Card
Version Model Number74014
Catalog Number74014
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
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
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
Handling Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM90174014 [Primary]
HIBCCM901740141 [Package]
Package: PACK [25 Units]
In Commercial Distribution
HIBCCM901740142 [Package]
Package: PACK [50 Units]
In Commercial Distribution
HIBCCM901740143 [Package]
Package: PACK [100 Units]
In Commercial Distribution

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-09
Device Publish Date2019-10-01

On-Brand Devices [QuickProfile™ Amphetamine Test Card]

M90174014Immunoassay for the detection of amphetamine in human urine
M90107RD70141Immunoassay for the detection of amphetamine in human urine

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.