FDA.reportPublic FDA data

MD DugScreen

Primary DI
00850969007776
Brand
MD DugScreen
Company
MEDICAL DISPOSABLES CORP
Model
MDC-375
Device description
CLIA Waived Drug Test Cup-(THC-COC-MOP-MET-BZO-OXY-BUP)
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
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850969007776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850969007776008509690077768509690077760850969007776

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810173655993HealgenHealgen Scientific Limited Liability CompanyJXM2026-03-11
10810173655597HealgenHealgen Scientific Limited Liability CompanyJXM2026-02-04
10810173655658HealgenHealgen Scientific Limited Liability CompanyJXM2026-02-04
00810173655101HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-31
10810173655603HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-30
10810173655641HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-30
00810173654821HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-08
00810173654838HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-08
00850054026989QMedix™Diagnostic Automation, Inc.JXM2025-12-23
00850054026996QMedix™Diagnostic Automation, Inc.JXM2025-12-23
10810173654002HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
10810173654149HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
10810173654644HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
00850013035830Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCJXM2025-12-04
0081703802225210 Panel Drug Test CupUCP BIOSCIENCES, INC.JXM2025-03-24
10815845024305SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.JXM2024-12-17
00841824105409N/AW.H.P.M. INC.JXM2024-06-14
10810124273023SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300)ALERE SAN DIEGO, INC.JXM2023-12-15
10810124273283SureStep™ Urine Test Drug Screen Cassette, Benzodiazepines (BZO 300)ALERE SAN DIEGO, INC.JXM2023-12-15
10810124273726CERTUM BZO One Step Benzodiazepines Test StripALERE SAN DIEGO, INC.JXM2023-12-15
00817763022367First SignHEMOSURE INC.JXM2023-05-18
04015630999347ONLINE DAT Benzodiazepines IIRoche Diagnostics GmbHJXM2023-05-11
07613336121054ONLINE DAT Benzodiazepines IIRoche Diagnostics GmbHJXM2023-05-11
00850041101750Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
00850041101781Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
00850041101798Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
10817405022936iCup™Instant Technologies, Inc.JXM2023-02-09
30817405022282iScreen™Instant Technologies, Inc.JXM2023-02-07
30817405022565iCassette™Instant Technologies, Inc.JXM2023-02-07
B77830573OD0Origin Instant Dip Drug TestORIGIN DIAGNOSTICS LLCJXM2022-12-07