Identify Diagnostics Drug Test Cups ID-CP13

GUDID 20850721007154

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

MEDICAL DISTRIBUTION GROUP INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID20850721007154
NIH Device Record Key9d677178-d12c-433e-a2dd-2d1eebf3613c
Commercial Distribution StatusIn Commercial Distribution
Brand NameIdentify Diagnostics Drug Test Cups
Version Model NumberID-CP13
Catalog NumberID-CP13
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
GS100850721007150 [Unit of Use]
GS110850721007157 [Primary]
GS120850721007154 [Package]
Contains: 10850721007157
Package: case [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

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 Diagnostics Drug Test Cups]

208507210073386-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
208507210073215-Panel Drug Screening Test Cup BUP/BZO/MOP/OXY/THC
2085072100731413-Panel Drug Screening Test Cup BUP/THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/OXY
2085072100730710-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
2085072100729112-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
2085072100728412-Panel Drug Screening Test Cup AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/MOP/OXY /PCP/THC with Adultera
2085072100720810-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
208507210071928-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MTD/MET/MOP/OXY
208507210071856-Panel Drug Screening Test Cup BUP/BZO/COC/MOP/OXY/MTD
208507210071785-Panel Drug Screening Test Cup BUP/BZO/MOP/OXY/THC
208507210071615-Panel Drug Screening Test Cup THC/OXY/MOP/BZO/COC
2085072100715413-Panel Drug Screening Test Cup BUP/THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/OXY
2085072100714712-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
208507210071306-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
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