FDA.reportPublic FDA data

QuickProfile™ Barbiturate Test Card

Primary DI
M90107RD70161
Brand
QuickProfile™ Barbiturate Test Card
Company
LUMIQUICK DIAGNOSTICS, INC.
Model
07RD7016
Catalog number
07RD7016
Device description
Immunoassay for the detection of barbiturate in human urine
Published
2017-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DKXThin Layer Chromatography, Barbiturate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKXThin Layer Chromatography, BarbiturateClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M90107RD70161PackageHIBCC25In Commercial Distribution
M90107RD70160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length75Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-408-855-0061udi@lumiquick.com

Regulatory Flags#

DUNS number
790175165
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M90107RD7205060QuickProfile™ Drugs of Abuse Test Cup07RD7205-0607RD7205-062026-03-11
M90107RD7205110QuickProfile™ Drugs of Abuse Test Cup07RD7205-1107RD7205-112026-03-10
M90107RD7205030QuickProfile™ Drugs of Abuse Test Cup07RD7205-0307RD7205-032026-03-10
M90107RD7205040QuickProfile™ Drugs of Abuse Test Cup07RD7205-0407RD7205-042026-03-10
00855636003808QuickProfile™ Covid-19/FluA&B Antigen Combo Test71118-1T71118-1T2023-09-01
M90107RD7206120QuickProfile™ Drugs of Abuse Test Cup07RD7206-1207RD7206-122022-12-02
M90107RD7205100QuickProfile™ Drugs of Abuse Test Cup07RD7205-1007RD7205-102022-07-12
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 Test07RD7065-2207RD7065-222017-11-15
M90107RD70050QuickProfile™ Methamphetamine Test Strip07RD700507RD70052017-11-15
M90107RD70070QuickProfile™ Cocaine Test Strip07RD700707RD70072017-11-15
M90107RD70080QuickProfile™ Cocaine Test Card07RD700807RD70082017-11-15
M90107RD70090QuickProfile™ THC Test Strip07RD700907RD70092017-11-15
M90107RD70100QuickProfile™ THC Test Card07RD701007RD70102017-11-15
M90107RD70110QuickProfile™ Opiate Test Strip07RD701107RD70112017-11-15
M90107RD70120QuickProfile™ Opiate Test Card07RD701207RD70122017-11-15
M90107RD70130QuickProfile™ Amphetamine Test Strip07RD701307RD70132017-11-15
M90107RD70140QuickProfile™ Amphetamine Test Card07RD701407RD70142017-11-15
M90107RD70150QuickProfile™ Barbiturate Test Strip07RD701507RD70152017-11-15
M90107RD70160QuickProfile™ Barbiturate Test Card07RD701607RD70162017-11-15
M90107RD70170QuickProfile™ Benzodiazepine Test Strip07RD701707RD70172017-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00096295140583LEADERCardinal Health 110, Inc.DKX2021-06-11
M90107RD70150QuickProfile™ Barbiturate Test StripLUMIQUICK DIAGNOSTICS, INC.DKX2017-11-15
M90107RD70160QuickProfile™ Barbiturate Test CardLUMIQUICK DIAGNOSTICS, INC.DKX2017-11-15
M90107RD70151QuickProfile™ Barbiturate Test StripLUMIQUICK DIAGNOSTICS, INC.DKX2017-11-15
00817830020197RAPID DIAGNOSTICS BARBITURATE TEST STRIP KIT (50)RAPID DIAGNOSTICS INCDKX2016-10-24
00817830020074RAPID DIAGNOSTICS BARBITURATE TEST STRIPRAPID DIAGNOSTICS INCDKX2016-10-20