MD DrugScreen

GUDID 00860146001527

Fecal Occult Blood (FOB) Rapid Test Device (Feces)

MEDICAL DISPOSABLES CORP

Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00860146001527
NIH Device Record Keyffff6bd8-7dbd-4866-9d17-3c5ef10cadaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameMD DrugScreen
Version Model NumberMDiFOB25
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
GS100860146001527 [Primary]

FDA Product Code

KHEReagent, Occult Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-07
Device Publish Date2018-04-06

On-Brand Devices [MD DrugScreen]

00860146001596CLIA Waived 8 Panel Cup w/6-AD (THC50/COC150/OPI300/AMP500/MET500/OXY100/MDMA500/PCP25)+ (NIT-GL
00860146001589CLIA Waived Drug Test Cup (THC-COC-MOP-AMP-MET-PCP-BZO-TCA-BAR-OXY-PPX-BUP-MTD)
00860146001572CLIA Waived Drug Test Cup (THC-COC-MOP-AMP-MET-PCP-BZO-TCA-BAR-OXY-PPX-BUP-MTD)
00860146001565CLIA Waived Drug Test Cup (THC-COC-MOP-AMP-MET-PCP-BZO-TCA-BAR-OXY-PPX-BUP-MTD)
00860146001558CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-OPI-AMP-MET-PCP-BZO-BAR-MDMA-
00860146001541CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-OPI-AMP-MET-PCP-BZO-BAR-MDMA-
00860146001534CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-OPI-AMP-MET-PCP-BZO-BAR-MDMA-OXY)+ (NIT-GLUT-
00860146001527Fecal Occult Blood (FOB) Rapid Test Device (Feces)
00860146001510Fecal Occult Blood (FOB) Rapid Test Device (Feces)
00860146001503Fecal Occult Blood (FOB) Rapid Test Device (Feces)
00860113002014CLIA Waived 8 Panel Cup w/6-AD (THC50/COC150/OPI300/AMP500/MET500/OXY100/MDMA500/PCP25)+ (NIT-GL
00860113002007CLIA Waived 8 Panel Cup w/6-AD (THC50/COC150/OPI300/AMP500/MET500/OXY100/MDMA500/PCP25)+ (NIT-GL
00851721007997CLIA Waived Drug Test Cup (THC/COC/OPI/MET/AMP/BZO/MTD/OXY/MDMA/BUP)+ Alcohol
00851721007980CLIA Waived Drug Test Cup (THC/COC/OPI/MET/AMP/BZO/MTD/OXY/MDMA/BUP)+ Alcohol
00851721007973CLIA Waived Drug Test Cup-(THC/COC/OPI/MET/AMP/BZO/MTD/OXY/MDMA/BUP)+ Alcohol
00851721007966M-DOA-565 CLIA Waived 6 Panel Drug Test Card-(THC-COC-MOP-MET-BZO-OXY)
00851721007959M-DOA-565 CLIA Waived 6 Panel Drug Test Card-(THC-COC-MOP-MET-BZO-OXY)
00851721007942M-DOA-565 CLIA Waived 6 Panel Drug Test Card-(THC-COC-MOP-MET-BZO-OXY)
00851721007935CLIA Waived Opiates Test Panel (OPI)
00851721007928CLIA Waived Opiates Test Panel (OPI)
00851721007911CLIA Waived Opiates Test Panel (OPI)
00851721007904CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-MOP-AMP-MET-BUP-MTD-MDMA-PCP-OXY)+(NIT-GLUT-C
00851721007898CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-MOP-AMP-MET-BUP-MTD-MDMA-PCP-OXY)+(NIT-GLUT-C
00851721007881CLIA Waived Drug Test Cup w/6 Adulterants (THC-COC-MOP-AMP-MET-BUP-MTD-MDMA-PCP-OXY)+(NIT-GLUT-C
00851721007874CLIA Waived Drug Test Cup (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP/TCA)
00851721007867CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/OXY/MDMA/BUP) +(O
00851721007850CLIA Waived 2 Panel Drug Test Card (BUP/TCA)
00851721007843CLIA Waived Drug Test Cup (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP/TCA)
00851721007836CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/OXY/MDMA/BUP) +(O
00851721007829CLIA Waived Drug Test Cup (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP/TCA)
00851721007812CLIA Waived Drug Test Cup w/3 Adulterants (THC/COC/AMP/MET/BAR/BZO/MOP/PCP/MTD/OXY/MDMA/BUP) +(O
00851721007805CLIA Waived 2 Panel Drug Test Card (BUP/TCA)
00860113002076CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
00860113002069CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
00860113002052CLIA Waived 9 Panel Drug Test Cup (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
00860113002045CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
00860113002038CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
00860113002021CLIA Waived 9 Panel Drug Test Card (COC/OPI/AMP/MET/MTD/OXY/BAR/BZO/BUP)
00860001731989CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDD
00860001731972CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDD
00860001731965CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/ED
00860001731958CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adult
00860001731941CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adult
00860001731934CLIA Waived 12 Panel Drug Test Cup w/AD (COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adul
10851721007802CLIA Waived 2 Panel Drug Test Card (BUP/TCA)
00860113002083MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY1
00860007913129MDC-855 5 Panel Cup CLIA Waived (COC300/MET1000/AMP1000/MOP300 /OXY100)
00860007913112MDC-855 5 Panel Cup CLIA Waived (COC300/MET1000/AMP1000/MOP300 /OXY100)
00860007913105MDC-855 5 Panel Cup CLIA Waived (COC300/MET1000/AMP1000/MOP300 /OXY100)
00860003196991MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY1
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.