AmediCheck Instant Test Cup C-C1012A-3A

GUDID 00816565020557

THC, COC, OPI, AMP, MET, MDMA, BAR, BZO, MTD, OXY with Adulteration Screen for OX/SG/PH

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: 00816565020557
• NIH Device Record Key: f53414f2-3921-4341-8690-1280fc5c3a0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmediCheck Instant Test Cup
• Version Model Number: C-C1012A-3A
• Catalog Number: C-C1012A-3A
• 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
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• Phone: 1-858-535-1968
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• Phone: 1-858-535-1968
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• Phone: 1-858-535-1968
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• Phone: 1-858-535-1968
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• Phone: 1-858-535-1968
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• Phone: 1-858-535-1968
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• Phone: 1-858-535-1968
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• Phone: 1-858-535-1968
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• Phone: 1-858-535-1968
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• Phone: 1-858-535-1968
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• Phone: 1-858-535-1968
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• 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	00816565020557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063379

FDA Product Code

• NGL: Test, Opiates, Over The Counter

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