FDA.reportPublic FDA data

MD DugScreen

Primary DI
00850969007738
Brand
MD DugScreen
Company
Medical Disposables Corp
Model
MDC-274AD
Device description
CLIA Waived Drug Test Cup w/ 6 Adulterants-(THC-COC-OPI-MET-BZO-OXY-AMP)
Published
2017-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850969007738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850969007738008509690077388509690077380850969007738

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 one or 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961673774
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
00810143451733MD DrugScreenMDC-7108-AD2026-03-18
00810143451740MD DrugScreenMDC-7108-AD2026-03-18
00810143451757MD DrugScreenMDC-7108-AD2026-03-18
00860007913167MD DrugScreenMDC-6135F2026-03-18
00810143451603MD DrugScreenMDC-03194AD2025-10-10
00850041101750Onsite DrugScreenODTC-61252023-04-24
00810143451450EndoGuidace ESU Button PencilMD-ESU-D0062024-10-22
00810143451467EndoGuidace ESU Button PencilMD-ESU-D0062024-10-22
00810143451474EndoGuidace ESU Button PencilMD-ESU-D0062024-10-22
00810143451412MD DrugScreenM-DFN-114C2024-09-13
00810143451429MD DrugScreenM-DFN-114C2024-09-13
00810143451443MD DrugScreenM-DFN-114C2024-09-13
00810143451207EndoGuidance L-Hook ElectrodeMDPL-332024-03-19
00810143451214EndoGuidance L-Hook ElectrodeMDPL-332024-03-19
00810143451221EndoGuidance L-Hook ElectrodeMDPL-332024-03-19
00810143451061MD EndoGuidance InnoClip Titanium Ligation SystemMTDC-10-ML2023-12-15
00810143451078MD EndoGuidance InnoClip Titanium Ligation SystemMTDC-10-ML2023-12-15
00810143451054MD EndoGuidance InnoClip Titanium Ligation SystemMTDC-10-ML2023-11-06
00810143450002MD EndoGuidanceMD5-1002023-07-31
00810143450033MD EndoGuidanceMD10-1002023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDKZ2023-04-28
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2021-06-24
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDKZ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2019-03-11
10694644500407RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-12-05
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-10-29
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-06-20
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-05-23
10722355002573Detector Drug CupImmunostics Company, IncDKZ2018-05-21
10722355002580Detector Drug CupImmunostics Company, IncDKZ2018-05-21
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-04-19
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-03-23
10694644500377RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-03-14
10694644500384RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-03-14
10694644400684INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-02-16
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-02-13
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2017-10-12
10694644400677INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2017-10-10
10694644500278RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2017-10-06
10694644500285RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2017-10-06
10694644500292RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2017-10-06