FDA.reportPublic FDA data

LEADER

Primary DI
50096295140571
Brand
LEADER
Company
CARDINAL HEALTH, INC.
Model
5688320
Catalog number
5688320
Device description
LDR At-Home Drug Test (5 drugs tested)
Published
2021-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DNKThin layer chromatography, morphine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DNKThin Layer Chromatography, MorphineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50096295140571PackageGS16In Commercial Distribution
00096295140576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5009629514057150096295140571
00096295140576000962951405760962951405760096295140576

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)200-6313xxx@xxx.xxx

Regulatory Flags#

DUNS number
097537435
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812203030766Premier BiotechCHEMTRON BIOTECH INCDNK2024-05-28
00812203030773Premier BiotechCHEMTRON BIOTECH INCDNK2024-05-28
00812203030711GenericCHEMTRON BIOTECH INCDNK2024-04-08
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.DNK2024-02-09
06970429841345DTPMCo-Innovation Biotech Co., LtdDNK2023-12-08
06970429841635DTPMCo-Innovation Biotech Co., LtdDNK2023-12-08
16936983144664DiscoverHangzhou AllTest Biotech Co., Ltd.DNK2023-11-30
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.DNK2023-11-30
00722066006757L-CupBTNX IncDNK2023-04-05
06970429841819co-innovationCo-Innovation Biotech Co., LtdDNK2022-11-11
00812203030575Premier BiotechCHEMTRON BIOTECH INCDNK2022-04-18
00812203030568Premier BiotechCHEMTRON BIOTECH INCDNK2022-04-14
00722066005507Rapid ResponseBTNX IncDNK2022-02-10
00722066005514Rapid ResponseBTNX IncDNK2022-02-10
06970429841444co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
06970429841536co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
06970429841628co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
06970429841703co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
06970429841802co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
06970429841901co-innovationCo-Innovation Biotech Co., LtdDNK2022-01-15
00041520113405Care One Ahold U.S.A., Inc.DNK2021-08-26
06974464590145DochekGuangzhou Decheng Biotechnology Co., LTDDNK2021-07-30
06974464590152DochekGuangzhou Decheng Biotechnology Co., LTDDNK2021-07-30
00812203030377OSTSCHEMTRON BIOTECH INCDNK2021-06-29
00812203030360Premier BiotechCHEMTRON BIOTECH INCDNK2021-06-25
00096295140576LEADERCardinal Health 110, Inc.DNK2021-06-11
00096295140583LEADERCardinal Health 110, Inc.DNK2021-06-11
00812203030513ChemtrueCHEMTRON BIOTECH INCDNK2021-06-08
00812203030223GenericCHEMTRON BIOTECH INCDNK2021-05-20
00812203030506Premier BiotechCHEMTRON BIOTECH INCDNK2021-05-04