QuickTox Drug Screen Dipcard QT80F-CE

GUDID 00816565021493

COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/TCA1000/OXY100/MDMA500

AMEDITECH INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00816565021493
NIH Device Record Key16a0318a-266c-4070-8d87-a60dada74957
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuickTox Drug Screen Dipcard
Version Model NumberQT80F-CE
Catalog NumberQT80F-CE
Company DUNS010551716
Company NameAMEDITECH INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx
Phone1-858-535-1968
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816565021493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs

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 Date2017-09-19

On-Brand Devices [QuickTox Drug Screen Dipcard]

00816565021523COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDMA500/BUP10 with Ni, Gl,
00816565021493COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/TCA1000/OXY100/MDMA500
00816565021486COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDMA500
00816565021479COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100/BUP10
00816565021462COC300/OPI300/THC50/AMP1000/BZO300/BAR300
00816565021455COC300/OPI300/MET500/THC50/AMP1000
00816565021448COC300/OPI300/AMP1000/THC50/BZO300
00816565021431COC300/OPI300/MET500/THC50/BZO300
00816565021233COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDMA500/BUP10
00816565021226COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/TCA1000/OXY100/MDMA500 with Positi
00816565021219COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDMA500 Adulteration Screen
00816565021202COC300/OPI300/MET500/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300/OXY100/MDMA500
00816565021196COC300/OPI2000/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100/MDMA500
00816565021189COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100/BUP10
00816565021172COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100 Adulteration Screen for CR-NI-PH-
00816565021165COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/MTD300/OXY100
00816565021158COC300/OPI2000/MET1000/THC50/AMP1000/PCP25/BZO300/BAR300/MTD300 Adulteration Screen for CR-NI-PH
00816565021141COC300/OPI300/MET500/THC50/AMP1000/BZO300/BAR300/OXY100
00816565021134COC300/OPI2000/MET500/THC50/AMP1000/PCP25 Adulteration Screen for NI-GL-CR-PH-SG-OX
00816565021127COC300/OPI2000/MET500/THC50/AMP1000/PCP25
00816565021110COC300/OPI300/THC50/AMP1000/BZO300/BAR300
00816565021103COC300/OPI2000/THC50/AMP1000/PCP25 Adulteration Screen for PH-SG-OX
00816565021097COC300/OPI2000/MET500/THC50/AMP1000
00816565021080COC300/OPI300/MET500/THC50/AMP1000
00816565021073OPI300/THC50/AMP1000/MET1000/BZO300 Adulteration Screen for CR-NI-PH-OX
00816565021066COC300/OPI300/AMP1000/THC50/BZO300
00816565021059COC300/OPI300/MET500/THC50/BZO300
00816565021042COC300/OPI2000/THC50/AMP1000/PCP25
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