Identify Home Drug Testing Device Test Cups ID-CP12-BUP

GUDID 20850721007062

12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY

MEDICAL DISTRIBUTION GROUP INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID20850721007062
NIH Device Record Keye0af5ed9-deaa-4f4d-bc95-f2f009db4056
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdentify Home Drug Testing Device Test Cups
Version Model NumberID-CP12-BUP
Catalog NumberID-CP12-BUP
Company DUNS064177324
Company NameMEDICAL DISTRIBUTION GROUP INC
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850721007068 [Unit of Use]
GS110850721007065 [Primary]
GS120850721007062 [Package]
Contains: 10850721007065
Package: case [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJREnzyme Immunoassay, Methadone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-05-24
Device Publish Date2016-08-30

On-Brand Devices [Identify Home Drug Testing Device Test Cups]

2085072100735210-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
2085072100734512-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
2085072100727713-Panel Drug Screening Test Cup BUP/THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/OXY
2085072100726010-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
2085072100724612-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
2085072100723910-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
208507210072226-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
208507210070936-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
2085072100708612-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/OXY
208507210070796-Panel Drug Screening Test Cup BUP/BZO/COC/MOP/OXY/MTD
2085072100706212-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
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