U-Screen USSCupA-12CLIA

GUDID 00858998006128

U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BAR/BZO/PCP/MDMA/MTD/OXY/TCA)

Instant Tech Subsidiary Acquisition

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

• Primary Device ID: 00858998006128
• NIH Device Record Key: bdf349ee-9e63-4725-ba3f-5fbc5d764b4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U-Screen
• Version Model Number: USSCupA-12CLIA
• Catalog Number: USSCupA-12CLIA
• Company DUNS: 080317182
• Company Name: Instant Tech Subsidiary Acquisition
• 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: false
• 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: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com
• Phone: 888.669.4337
• Email: james.harvey@usdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858998006128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

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: 2016-10-26

On-Brand Devices [U-Screen]

• 00858998006418: U-Screen Squared Integrated Cup with 4 Panel Drug Screen for (COC/OPI2000/AMP/MET).
• 00858998006197: 6-Panel UScreen Dip Drug Screen (THC/COC/OPI2000/AMP/MET/BZO)
• 00858998006180: U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for
• 00858998006173: U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for (THC/COC/MOP
• 00858998006166: U-Screen Squared Integrated Cup with Adulterants 7 Panel Drug Screen (CR,SG,OX) for (THC/COC/OPI
• 00858998006159: U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (THC/COC/OPI
• 00858998006142: U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen for (THC/COC/OPI
• 00858998006135: U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen fo
• 00858998006128: U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for
• 00858998006111: U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for
• 00858998006104: U-Screen Squared Integrated Cup with Adulterants(CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP
• 00858998006098: U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 12 Panel Drug Screen for (THC/COC/OP
• 00858998006081: U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for
• 00858998006074: U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/MO
• 00858998006067: U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/OP
• 00858998006050: U-Screen Squared Integrated CLIA Waived Cup 7 Panel Drug Screen for (THC/COC/OPI300/AMP/BUP/BZO/
• 00858998006043: U-Screen Squared Integrated Cup 5 Panel Drug Screen for (THC/COC/OPI2000/MET/BZO)
• 00858998006036: U-Screen Squared Integrated Cup with 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
• 00858998006029: UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR/BZO/MDMA/MTD/OXY)
• 00858998006012: U-Screen Squared Integrated Cup 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MD
• 00858998006005: 6-Panel UScreen Dip Drug Screen (THC/COC/OPI2000/MAMP/BZO/OXY)