FDA.reportPublic FDA data

MD DugScreen

Primary DI
00850969007301
Brand
MD DugScreen
Company
MEDICAL DISPOSABLES CORP
Model
M-DOA-1124
Device description
CLIA Waived 12 Panel Drug Test Card-(THC-COC-OPI-AMP-MET-PCP-BZ0-BAR-MTD-MDMA-OXY-PPX)
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
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850969007301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850969007301008509690073018509690073010850969007301

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
10810173655962HealgenHealgen Scientific Limited Liability CompanyLCM2026-03-11
10810173655566HealgenHealgen Scientific Limited Liability CompanyLCM2026-02-04
00810173654920HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
00810173655071HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
10810173655085HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
10810173654774HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-08
10810173654798HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-08
00812101031599ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031605ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031612ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031995ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
10810173654538Healgen Healgen Scientific Limited Liability CompanyLCM2025-12-19
10810173654576HealgenHealgen Scientific Limited Liability CompanyLCM2025-12-19
10810173654637HealgenHealgen Scientific Limited Liability CompanyLCM2025-12-19
08500130357170Identify® Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035809Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035878Identify® Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
00850013035076Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLCM2025-09-11
10816862026785Prime ScreenWONDFO USA CO., LTD.LCM2025-07-03
10816862026358SAFElife™WONDFO USA CO., LTD.LCM2024-12-24
10815845023162SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LCM2024-12-17
00817763022510First Sign®HEMOSURE INC.LCM2024-10-16
00812203030780DrugSmart CupCHEMTRON BIOTECH INCLCM2024-07-29
10810124273245SureStepTM Urine Test Drug Screen Strip, Phencyclidine (PCP 25)ALERE SAN DIEGO, INC.LCM2023-12-15
00858886006827Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLCM2023-10-20
00817815021119CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.LCM2023-08-23
10690286000763PROFILE®-V MEDTOXScan®MEDTOX DIAGNOSTICS, INC.LCM2023-08-01
30817405023821iScreen™Instant Technologies, Inc.LCM2023-05-01
30817405023883iScreen™Instant Technologies, Inc.LCM2023-05-01
30817405021711iScreen™Instant Technologies, Inc.LCM2023-02-07