FDA.reportPublic FDA data

MD DrugScreen

Primary DI
00810143451603
Brand
MD DrugScreen
Company
Medical Disposables Corp
Model
MDC-03194AD
Device description
MDC-03194AD For Forensic Use Only 6-MAM10/AMP500/BAR300/BUP10/BZO300/COC150/ETG300/FEN1/K2(25)/KET100/KRA250/ MET500/MDMA500/MOP300/MTD300/OXY100/PCP25
Published
2025-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DMJTest Reagents For Ethyl Alcohol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DMJTest Reagents For Ethyl AlcoholClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143451603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143451603008101434516038101434516030810143451603

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA 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 [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

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
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
00810143450064MD EndoGuidanceMD12-1002023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810143620047GenaCheck Alcohol Rapid Self-Test KitGenabio Diagnostics Inc.DMJ2023-10-06
10810143620044GenaCheck Alcohol Rapid Self-Test KitGenabio Diagnostics Inc.DMJ2023-10-06
00850041101750Onsite DrugScreenMedical Disposables CorpDMJ2023-04-24
D82852000580Zendura Clear Retainer - LowerFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCDMJ2022-12-12
D82852000590Dual-Laminate Essix LowerFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCDMJ2022-12-12
06970429841420co-innovationCo-Innovation Biotech Co., LtdDMJ2018-10-08
00895330002752Healgen (Private Label) EtG Urine Dip *300ngCONFIRM BIOSCIENCES, INC.DMJ2016-09-06