DrugSmart Dip C30140D

GUDID 00850019007435

DrugSmart Dip 1 THC CLIA-Waived, 25pcs/kit

CHEMTRON BIOTECH INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00850019007435
NIH Device Record Key366bb933-de70-4983-9930-87f93fc63dc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrugSmart Dip
Version Model NumberC30140D
Catalog NumberC30140D
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
GS100850019007435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

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 Date2016-06-27

On-Brand Devices [DrugSmart Dip]

00850019007473DrugSmart Dip 13 CLIA-Waived, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/TCA/THC, 25pcs/kit
00850019007466DrugSmart Dip 9 CLIA-Waived, AMP/BUP/BZO/COC/MET/MTD/OPI2000/OXY/THC, 25pcs/kit
00850019007442DrugSmart Dip 1 BUP CLIA-Waived, 25pcs/kit
00850019007435DrugSmart Dip 1 THC CLIA-Waived, 25pcs/kit
00850019007107DrugSmart Dip 7 BUP/BZO/COC/MTD/MOR300/OXY/THC, 25pcs/kit
00850019007091DrugSmart Dip 6, AMP/BAR/BZO/COC/MET/THC, 25pcs/kit
00850019007084DrugSmart Dip 6, AMP/BZO/COC/MET/OPI2000/THC, 25pcs/kit
00850019007077DrugSmart Dip 5, AMP/BAR/COC/OPI2000/THC ,25pcs/kit
00850019007060DrugSmart Dip 5, AMP/BAR/BZO/COC/THC, 25pcs/kit
00850019007053DrugSmart Dip 4, AMP/COC/MET/THC, 25pcs/kit
00850019007046DrugSmart Dip 1 BUP, 25pcs/kit
00812203030636DrugSmart Dip 5, AMP/COC/MET/OPI2000/THC, 25pcs/kit

Trademark Results [DrugSmart Dip]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DRUGSMART DIP
DRUGSMART DIP
77381997 3492348 Live/Registered
TWIN SPIRIT, INC.
2008-01-28
DRUGSMART DIP
DRUGSMART DIP
77014153 not registered Dead/Abandoned
Twin Spirit, Inc.
2006-10-04

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