AmediCheck Instant Test Cup C-60B02

GUDID 00816565020595

THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MTD, TCA, OXY Drugs of Abuse Test Cup

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 ID	00816565020595
NIH Device Record Key	7373143f-ec68-4915-a206-8a424bd69f0a
Commercial Distribution Status	In Commercial Distribution
Brand Name	AmediCheck Instant Test Cup
Version Model Number	C-60B02
Catalog Number	C-60B02
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	true

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 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816565020595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K063379

FDA Product Code

DJC	Thin Layer Chromatography, Methamphetamine

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	2017-03-31

On-Brand Devices [AmediCheck Instant Test Cup]

00816565020595	THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MTD, TCA, OXY Drugs of Abuse Test Cup
00816565020588	THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY Drugs of Abuse Test Cup
00816565020571	COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY Drugs of Abuse Test Cup
00816565020564	THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, OXY Drugs of Abuse Test Cup
00816565020557	THC, COC, OPI, AMP, MET, MDMA, BAR, BZO, MTD, OXY with Adulteration Screen for OX/SG/PH
00816565020540	COC, OPI300, AMP, MET, BZO, OXY with Adulteration Screen for OX/SG/PH
00816565020533	THC, COC, OPI, AMP, MET, PCP with Adulteration Screen for OX/SG/PH
00816565020526	THC, COC, OPI, AMP, MET with Adulteration Screen for OX/SG/PH
00816565020519	THC, COC, OPI, MET, PCP with Adulteration Screen for OX/SG/PH
00816565020502	THC, COC, OPI, AMP, PCP with Adulteration Screen for OX/SG/PH