MD DrugScreen

GUDID 00860001731996

CLIA Waived 5 Panel Drug Test Cup (THC50/COC300/OPI2000/AMP1000/MET1000)

MEDICAL DISPOSABLES CORP

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00860001731996
NIH Device Record Key52599f3d-06cd-47a6-894c-1863e3ba1dd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMD DrugScreen
Version Model NumberMDC-254R
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
GS100860001731996 [Primary]

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-27
Device Publish Date2020-01-17

On-Brand Devices [ MD DrugScreen]

00860003196984CLIA Waived 14 Panel Drug Test Card (THC50/COC300/OPI2000/AMP1000/MET1000)
00860003196977CLIA Waived 12 Panel Drug Test Cup w/ 3 adulterants (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/B
00860003196960CLIA Waived 12 Panel Drug Test Cup w/ 3 adulterants (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/B
00860003196946CLIA Waived 12 Panel Drug Test Cup w/ 3 adulterants (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/B
00860003196939CLIA Waived 12 Panel Drug Test Cup (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDM
00860003196922CLIA Waived 12 Panel Drug Test Cup (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDM
00860003196915CLIA Waived 12 Panel Drug Test Cup (THC50/COC300/OPI300/AMP1000/MET1000/PCP25/BZO300/BAR300/MDM
00860003196908CLIA Waived 5 Panel Drug Test Card (THC50/COC300/OPI2000/AMP1000/MET1000)
00860001731996CLIA Waived 5 Panel Drug Test Cup (THC50/COC300/OPI2000/AMP1000/MET1000)

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