Instant Test Cup 10-300

GUDID 00816565020625

COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with Adulteration OX/SG/pH Drugs of Abuse Test Cup (CLIA WAIVED)

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, 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	00816565020625
NIH Device Record Key	6131e877-811e-4d87-a536-82d7e384f8e2
Commercial Distribution Discontinuation	2018-09-20
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Instant Test Cup
Version Model Number	10-300
Catalog Number	10-300
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	false
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

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816565020625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K082898

FDA Product Code

DJG	Enzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-09-21
Device Publish Date	2017-03-31

On-Brand Devices [Instant Test Cup]

00816565020625	COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with Adulteration OX/SG/pH Drugs of Abuse Test
00816565020618	COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100 with A
00816565020601	THC50, COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100