FDA.reportPublic FDA data

Onsite DrugScreen

Primary DI
00850041101750
Brand
Onsite DrugScreen
Company
Medical Disposables Corp
Model
ODTC-6125
Device description
CLIA WAIVED (THC/COC/OPI300/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP)
Published
2023-04-24
Public version status
Update
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
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041101750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041101750008500411017508500411017500850041101750

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.

Sterilization Methods#

Method table
Method

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
00810143451603MD DrugScreenMDC-03194AD2025-10-10
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
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00817405024247iScreen™Instant Technologies, Inc.JXM2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyJXM2026-07-31
00841824104167ECOIIW.H.P.M. INC.JXM2026-07-07
00810173656726HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyJXM2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyJXM2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035554Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035707Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
16936983149751Discover milti-drug12 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.JXM2024-02-09
16936983149744Discover milti-drug 7 drugs rapid test cupHangzhou AllTest Biotech Co., Ltd.JXM2024-02-08
16936983150634Discover milti-drug 8 drugs rapid test cup (urine)Hangzhou AllTest Biotech Co., Ltd.JXM2024-02-08
16936983144671DiscoverHangzhou AllTest Biotech Co., Ltd.JXM2023-11-30