eCUP + Drug Screening Device 94615

GUDID 00816565021530

13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni

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: 00816565021530
• NIH Device Record Key: 3edc8f16-e1fc-4cee-9357-168dae8c65ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eCUP + Drug Screening Device
• Version Model Number: 94615
• Catalog Number: 94615
• Company DUNS: 010551716
• Company Name: AMEDITECH INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false

Customer Support Contacts

• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 1-619-318-4969
• Email: angela.occhionero@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com
• Phone: 619-372-6179
• Email: Irene.Yasuda@abbott.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816565021530 [Primary]

FDA Product Code

• PVA: Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-25
• Device Publish Date: 2020-03-17

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• 00816565020380 - KNOWme™: 2023-05-09 KNOWme™ Dried Blood Spot Convenience Kit 4-spot
• 00816565021530 - eCUP + Drug Screening Device: 2020-03-2513 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni
• 00816565021530 - eCUP + Drug Screening Device: 2020-03-25 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni
• 00816565021547 - eREADER+ Drug Screening Instrument: 2020-03-13 ereader working with ecup +. 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,
• 00816565020274 - ImmuTest Drugs of Abuse Cup: 2019-01-30 6 panel test cup, AMP1000/COC150/MET500/OPI2000/PCP25/THC50 with Cr, Ni, pH, Bl, S.G. adulteration tests
• 00816565020281 - ImmuTest Drugs of Abuse Cup: 2019-01-30 8 Panel test cup, (OXY/MDMA)+(PCP/AMP1000)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
• 00816565020335 - ImmuTest Drugs of Abuse Cup: 2019-01-30 9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests