FDA.reportPublic FDA data

MD DugScreen

Primary DI
00851721007201
Brand
MD DugScreen
Company
MEDICAL DISPOSABLES CORP
Model
M-DBA-114
Device description
CLIA Waived Barbiturates Test Panel (BAR)
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
DISEnzyme Immunoassay, Barbiturate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851721007201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851721007201008517210072018517210072010851721007201

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
10810173655726HealgenHealgen Scientific Limited Liability CompanyDIS2026-01-30
00810173654760HealgenHealgen Scientific Limited Liability CompanyDIS2026-01-08
10810173653951HealgenHealgen Scientific Limited Liability CompanyDIS2025-12-19
10810173654057HealgenHealgen Scientific Limited Liability CompanyDIS2025-12-19
10810173654675HealgenHealgen Scientific Limited Liability CompanyDIS2025-12-19
10810124273849CERTUM One Step Multi-Drug Screen PanelALERE SAN DIEGO, INC.DIS2024-12-17
10815845023155SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.DIS2024-12-17
05055273216752Evidence MultiSTAT DOA Urine MultiPlexRANDOX LABORATORIES LIMITEDDIS2024-09-16
10817405024077iScreen™ Urine Test E-Z Split Key™ Drug Screen CupInstant Technologies, Inc.DIS2024-07-16
10810124273009SureStepTM Urine Test Drug Screen Strip, Barbiturates (BAR 300)ALERE SAN DIEGO, INC.DIS2023-12-15
10810124273276SureStep™ Urine Test Drug Screen Cassette, Barbiturates (BAR 300)ALERE SAN DIEGO, INC.DIS2023-12-15
10810124273719CERTUM BAR One Step Barbiturates Test StripALERE SAN DIEGO, INC.DIS2023-12-15
16970429841342DTPMCo-Innovation Biotech Co., LtdDIS2023-12-08
00817815021089CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.DIS2023-08-23
00817815021324CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.DIS2023-08-23
10690286000770PROFILE®-IIAMEDTOX DIAGNOSTICS, INC.DIS2023-06-01
10817405022806iCup™Instant Technologies, Inc.DIS2023-02-06
10817405023049iCup™Instant Technologies, Inc.DIS2023-02-06
30817405021476iScreen™Instant Technologies, Inc.DIS2023-02-01
B298608040DrugCheckExpress Diagnostic Int'l, Inc.DIS2022-10-14
B298610700DrugCheckExpress Diagnostic Int'l, Inc.DIS2022-07-22
00811727017178Pointe Barbiturate Reagent SetPOINTE SCIENTIFIC, INC.DIS2020-09-25
00811727017185Pointe Barbiturate Reagent SetPOINTE SCIENTIFIC, INC.DIS2020-09-25
10690286000701EZ-SCREEN® CUPMEDTOX DIAGNOSTICS, INC.DIS2020-08-04
07613336121030ONLINE DAT Barbiturates PlusRoche Diagnostics GmbHDIS2020-03-05
00860113002021MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
00860113002038MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
00860113002045MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
00860113002052MD DrugScreenMEDICAL DISPOSABLES CORPDIS2020-01-17
B29830150C10DrugCheckExpress Diagnostic Int'l, Inc.DIS2019-12-31