DrugSmart Cup C-60820D

GUDID 00859144006016

THC, COC, OPI, AMP, MET, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)

Twin Spirit Inc.

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

• Primary Device ID: 00859144006016
• NIH Device Record Key: 96bf2647-80df-485e-9444-5b558fbc57b7
• Commercial Distribution Discontinuation: 2018-06-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DrugSmart Cup
• Version Model Number: C-60820D
• Catalog Number: C-60820D
• Company DUNS: 617011296
• Company Name: Twin Spirit 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: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com
• Phone: 1-760-494-7502
• Email: info@nativediagnostics.com

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 2 Degrees Celsius and 30 Degrees Celsius
• 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 2 Degrees Celsius and 30 Degrees Celsius
• 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 2 Degrees Celsius and 30 Degrees Celsius
• 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 2 Degrees Celsius and 30 Degrees Celsius
• 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 2 Degrees Celsius and 30 Degrees Celsius
• 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 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859144006016 [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: 2020-01-28
• Device Publish Date: 2016-09-01

On-Brand Devices [DrugSmart Cup]

• 00859144006238: AMP/OPI300/COC/THC/MET/BZO/BAR/MTD/OXY/MDMA/BUP drugs of abuse test cup
• 00859144006221: THC/COC/OPI2000/AMP/MET/PCP/MDMA/BAR/BZO/MTD/PPX/OXY drugs of abuse test cup
• 00859144006214: PCP/AMP/THC/COC150/MET500/BAR/BZO/OPI300/OXY/MDMA with adulteration pH/CR/OX drugs of abuse test
• 00859144006207: THC/COC/AMP/MET/OPI drugs of abuse test cup
• 00859144006191: THC/COC/AMP/PCP/OPI drugs of abuse test cup
• 00859144006184: THC/COC/AMP/BAR/OPI drugs of abuse test cup
• 00859144006177: THC/COC/AMP/BZO/OPI/MET drugs of abuse test cup
• 00859144006160: THC/COC/AMP/MET/OPI/OXY drugs of abuse test cup
• 00859144006153: THC/COC/OPI/AMP/MET/BZO/MTD/OXY/BUP drugs of abuse test cup
• 00859144006146: COC/THC/BZO/AMP/BAR/OPI2000/MET/MDMA/TCA/PCP drugs of abuse tes cup
• 00859144006139: THC/COC/AMP/PCP/OPI/MET/BAR/BZO/MTD/OXY drugs of abuse test cup
• 00859144006122: THC/COC/BAR/BZO/MET/OPI300/MTD/PPX/OXY/MDMA drugs of abuse test cup
• 00859144006115: THC/COC/BAR/BZO/MET/OPI300/AMP/PPX/OXY/MDMA drugs of abuse test cup
• 00859144006108: THC/COC/AMP/BAR/BZO/MET/OPI300/PPX/OXY/BUP drugs of abuse test cup
• 00859144006092: THC/COC/AMP/MET/BAR/BZO/OPI/PCP/MDMA/MTD drugs of abuse test cup
• 00859144006085: THC/COC/AMP/MET/BAR/BZO/OPI/PCP/PPX/MTD drugs of abuse test cup
• 00859144006078: COC/THC/MET/OPI/AMP/MDMA/BAR/BZO/MTD/PPX/OXY/BUP drugs of abuse test cup
• 00859144006061: COC/THC/MET/OPI/AMP/BAR/BZO/MTD/PCP/PPX/OXY/BUP drugs of abuse test cup
• 00859144006054: THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAI
• 00859144006047: THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
• 00859144006030: THC, COC, OPI300, AMP, MET, PCP, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
• 00859144006023: THC, COC, OPI300, AMP, MET, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
• 00859144006016: THC, COC, OPI, AMP, MET, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
• 00859144006009: THC, COC, OPI, MET, BZO, OXY drugs of abuse test cup (CLIA WAIVED)