QuickTox Drug Screen Dipcard QT19-CE

GUDID 00816565021455

COC300/OPI300/MET500/THC50/AMP1000

AMEDITECH INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	00816565021455
NIH Device Record Key	0210e851-768b-4a65-9263-a4f9924b8d21
Commercial Distribution Status	In Commercial Distribution
Brand Name	QuickTox Drug Screen Dipcard
Version Model Number	QT19-CE
Catalog Number	QT19-CE
Company DUNS	010551716
Company Name	AMEDITECH INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx
Phone	1-858-535-1968
Email	xxx@xx.xx

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816565021455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K022355

FDA Product Code

LDJ	Enzyme Immunoassay, Cannabinoids

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2017-09-19

On-Brand Devices [QuickTox Drug Screen Dipcard]

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