DrugSmart Cup 60620D

GUDID 00850019007121

DrugSmart Cup 6, AMP/COC/THC/OPI/MET/OXY, 25pcs/kit

CHEMTRON BIOTECH INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00850019007121
NIH Device Record Keydd8f309f-b5e8-4ec0-b781-6990c9608306
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrugSmart Cup
Version Model Number60620D
Catalog Number60620D
Company DUNS795658603
Company NameCHEMTRON BIOTECH INC
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850019007121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LAFGas Chromatography, Methamphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-24

On-Brand Devices [DrugSmart Cup]

00850019007640DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/OPI2000/PCP/TCA/THC, 25 tests/kit
00850019007589DrugSmart Cup 9, AMP/BAR/BZO/COC/MTD/OPI2K/PCP/PPX/THC, 25tests/kit
00850019007503DrugSmart Cup 12, THC/COC/MOR300/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY, 25pcs/kit
00850019007497DrugSmart Cup 9, THC/COC/MOR300/AMP/MET/BZO/MTD/BUP/OXY, 25pcs/kit
00850019007480DrugSmart Cup 6, AMP/COC/THC/OPI2000/MET/OXY, 25pcs/kit
00850019007138DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI2000/TCA/THC, 25pcs/kit
00850019007121DrugSmart Cup 6, AMP/COC/THC/OPI/MET/OXY, 25pcs/kit
00850019007114DrugSmart Cup 5, AMP/COC/MET/OPI/THC, 25pcs/kit
00812203030698DrugSmart Cup 4, AMP/COC/MET/OPI2K, 25 tests/kit
00812203030780DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/OPI2K/PCP/TCA/THC + (Cr/SG/Ox)(Ni/pH/Gl)

Trademark Results [DrugSmart Cup]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DRUGSMART CUP
DRUGSMART CUP
77625474 3646777 Live/Registered
TWIN SPIRIT, INC.
2008-12-03

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