FDA.reportPublic FDA data

MD DugScreen

Primary DI
00850969007905
Brand
MD DugScreen
Company
MEDICAL DISPOSABLES CORP
Model
M-DCO-114
Device description
CLIA Waived Cocaine Test Panel (COC)
Published
2017-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850969007905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850969007905008509690079058509690079050850969007905

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
00810143450095MD EndoGuidanceMD15-1002023-07-31
00810143450125MD EndoGuidanceMD5-1502023-07-31
00810143450156MD EndoGuidanceMD10-1502023-07-31
00810143450187MD EndoGuidanceMD12-150 2023-07-31
00810143450217MD EndoGuidanceMDK5-1002023-07-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10810173655573HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-30
10810173655733HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-30
00810173654784HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-08
10810173655092HealgenHealgen Scientific Limited Liability CompanyDIO2026-01-08
10810173654590HealgenHealgen Scientific Limited Liability CompanyDIO2025-12-19
10810173654606HealgenHealgen Scientific Limited Liability CompanyDIO2025-12-19
10810173654620HealgenHealgen Scientific Limited Liability CompanyDIO2025-12-19
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00850721007679Identify® Diagnostics Drug Test CardsMEDICAL DISTRIBUTION GROUP INCDIO2025-09-11
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10810124273818CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
10810124273825CERTUM One Step Multi-Line Drug Screen EZ SplitALERE SAN DIEGO, INC.DIO2024-10-10
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