Onsite DrugScreen

GUDID 00850041101750

CLIA WAIVED (THC/COC/OPI300/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP)

Medical Disposables Corp

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00850041101750
NIH Device Record Key665a568c-d3bf-4481-b014-135fdbdba01c
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnsite DrugScreen
Version Model NumberODTC-6125
Company DUNS961673774
Company NameMedical Disposables Corp
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850041101750 [Primary]

FDA Product Code

JXMEnzyme Immunoassay, Benzodiazepine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-02
Device Publish Date2023-04-24

On-Brand Devices [Onsite DrugScreen]

00850041101798CLIA WAIVED (THC/COC/OPI300/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP)
00850041101781CLIA WAIVED (THC/COC/OPI300/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP)
00850041101750CLIA WAIVED (THC/COC/OPI300/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP)

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