ToxCup Drug Screen Cup HT15A

GUDID 00816565020700

AMP1000/COC300/MET500/PCP25/THC50/OPI2000 Adulteration Screen for CR/NI/PH/BL/SG

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	00816565020700
NIH Device Record Key	a21c0a3c-2a2c-45f5-ad49-a3e6b7fa0f84
Commercial Distribution Status	In Commercial Distribution
Brand Name	ToxCup Drug Screen Cup
Version Model Number	HT15A
Catalog Number	HT15A
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
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling 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	00816565020700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K032057

FDA Product Code

DKZ	Enzyme Immunoassay, Amphetamine

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 [ToxCup Drug Screen Cup]

00816565021417	COC300/MET500/OPI300/THC50/BZO300 Adulteration Strip for CR-NI-Ph-BL-SG
00816565021400	AMP1000/COC300/MET500/OPI300/THC50
00816565021356	COC300/AMP1000/OPI300/THC50/BZO300/BAR300/MDMA500
00816565021332	THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; PCP25/PPX300
00816565020830	COC300/MET500/OPI300/THC50/BZO300 Adulteration Screen for CR-NI-PH-BL-SG
00816565020823	AMP1000/COC300/MET500/OPI300/THC50 Adulteration Screen for CR-NI-PH-BL-SG
00816565020816	AMP1000/COC300/MET500/OPI300/THC50
00816565020809	AMP1000/COC300/MET500/OPI2000/THC50
00816565020793	COC300/MET500/OPI2000/PCP25/THC50 Adulteration Screen for CR-NI-PH-BL-SG
00816565020786	COC300/MET500/OPI2000/PCP25/THC50
00816565020779	AMP1000/COC300/OPI2000/PCP25/THC50 Adulteration Screen for CR-NI-PH-BL-SG
00816565020762	AMP1000/COC300/OPI2000/PCP25/THC50
00816565020755	AMP1000/COC300/BAR300/BZO300/MTD300/OXY100/OPI300 Adulteration Screen for CR-NI-PH-BL-SG
00816565020748	AMP1000/COC300/MET1000/PCP25/THC50/OPI2000
00816565020731	COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100 Adulteration Screen for CR-NI-PH-BL-SG
00816565020724	THC50/BZO300/COC300/OPI300/AMP1000/BAR300/MDMA500
00816565020717	COC300/MET500/OPI300/THC50/BZO300/BAR300/0XY100
00816565020700	AMP1000/COC300/MET500/PCP25/THC50/OPI2000 Adulteration Screen for CR/NI/PH/BL/SG
00816565020694	AMP1000/COC300/MET500/PCP25/THC50/OPI2000
00816565020687	THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; MDMA500/OXY100; BUPG10/TCA100; PCP25/
00816565020670	THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; MDMA500/OXY100; BUPG10/TCA100; PCP25/
00816565020663	THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA100; MDMA500/OXY100 with Cr
00816565020656	THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; MDMA500/OXY100; PCP25/PPX300 with Cr,
00816565020649	THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; PCP25/PPX300 with Cr, Ni, pH, Bl, S.G
00816565020632	THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; PCP25/PPX300
00816555020390	ToxCup® Drug Screen Cup (AMP300/COC300/MET500/OPI300/THC50/MDMA500/MTD300)