Identify Home Drug Testing Device Test Cups ID-CP12-AZ5

GUDID 20850721007246

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 ID20850721007246
NIH Device Record Keye514caff-add4-4a4a-8189-1e6af2f0d733
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdentify Home Drug Testing Device Test Cups
Version Model NumberID-CP12-AZ5
Catalog NumberID-CP12-AZ5
Company DUNS064177324
Company NameMEDICAL DISTRIBUTION GROUP INC
Device Count5
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
GS100850721007242 [Unit of Use]
GS110850721007249 [Primary]
GS120850721007246 [Package]
Contains: 10850721007249
Package: case [40 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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