FDA.reportPublic FDA data

RAPID DIAGNOSTICS BARBITURATE TEST STRIP KIT (50)

Primary DI
00817830020197
Brand
RAPID DIAGNOSTICS BARBITURATE TEST STRIP KIT (50)
Company
RAPID DIAGNOSTICS INC
Model
07RD8015
Catalog number
07RD8015
Device description
BARBITURATE TEST STRIP KIT (50)
Published
2016-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00817830020197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830020197008178300201978178300201970817830020197

GMDN Terms#

Term, Definition table
TermDefinition
Barbiturate 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 barbiturates 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length72Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-0530custserv@mpbio.com

Regulatory Flags#

DUNS number
008028248
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817830020166RAPID DIAGNOSTICS MARIJUANA (THC) TEST STRIP KIT (50)07RD800907RD80092016-10-20
00817830020029RAPID DIAGNOSTICS M-AMPHAMPHETAMINE TEST STRIP07RD700507RD70052016-10-20
00817830020036RAPID DIAGNOSTICS COCAINE TEST STRIP07RD700707RD70072016-10-20
00817830020050RAPID DIAGNOSTICS OPIATES TEST STRIP07RD701107RD70112016-10-20
00817830020074RAPID DIAGNOSTICS BARBITURATE TEST STRIP07RD701507RD70152016-10-20
00817830020081RAPID DIAGNOSTICS BENZODIAZEPINE TEST STRIP07RD701707RD70172016-10-20
00817830020098RAPID DIAGNOSTICS METHADONE TEST STRIP07RD701907RD70192016-10-20
00817830020104RAPID DIAGNOSTICS PCP TEST STRIP07RD702107RD70212016-10-20
00817830020111RAPID DIAGNOSTICS OPI/MOR TEST STRIP - 200007RD703907RD70392016-10-20
00817830020135RAPID DIAGNOSTICS BUPRENORPHINE TEST STRIP07RD710507RD71052016-10-20
00817830020142RAPID DIAGNOSTICS M-AMPHAMPHETAMINE TEST STRIP KIT (50)07RD800507RD80052016-10-24
00817830020159RAPID DIAGNOSTICS COCAINE TEST STRIP KIT (50)07RD800707RD80072016-10-24
00817830020173RAPID DIAGNOSTICS OPIATES TEST STRIP KIT (50)07RD801107RD80112016-10-24
00817830020180RAPID DIAGNOSTICS AMPHETAMINE TEST STRIP KIT (50)07RD801307RD80132016-10-20
00817830020203RAPID DIAGNOSTICS BENZODIAZEPINE TEST STRIP KIT (50)07RD801707RD80172016-10-24
00817830020210RAPID DIAGNOSTICS METHADONE TEST STRIP KIT (50)07RD801907RD80192016-10-24
00817830020227RAPID DIAGNOSTICS PCP TEST STRIP KIT (50)07RD802107RD80212016-10-24
00817830020234RAPID DIAGNOSTICS OPI/MOR 2000 TEST STRIP KIT (50)07RD803907RD80392016-10-24
00817830020241RAPID DIAGNOSTICS OXYCODONE TEST STRIP KIT (50)07RD810007RD81002016-10-20
00817830020258RAPID DIAGNOSTICS BUPRENORPHINE TEST STRIP KIT (50)07RD810507RD81052016-10-24

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
M90107RD70161QuickProfile™ Barbiturate Test CardLUMIQUICK DIAGNOSTICS, INC.DKX2017-11-15
00817830020074RAPID DIAGNOSTICS BARBITURATE TEST STRIPRAPID DIAGNOSTICS INCDKX2016-10-20