ToxCup Drug Screen Cup DT10

GUDID 00816565020632

THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; PCP25/PPX300

AMEDITECH INC.

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

• Primary Device ID: 00816565020632
• NIH Device Record Key: a0190456-0e37-4979-9a60-4aa6874ee3b8
• Commercial Distribution Discontinuation: 2018-04-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ToxCup Drug Screen Cup
• Version Model Number: DT10
• Catalog Number: DT10
• 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

Operating and Storage Conditions

• Handling 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816565020632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122633

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-15
• 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)