NexScreen Drug Screen Cup with AD NCard-12+4

GUDID 00858984006330

AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(OX/pH/SG)/(GL/NI/CR)

NEXSCREEN, LLC

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

• Primary Device ID: 00858984006330
• NIH Device Record Key: 22c4b259-35d8-4326-8fc5-d17836fce8a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexScreen Drug Screen Cup with AD
• Version Model Number: NCard-12+4
• Catalog Number: NCard-12+4
• Company DUNS: 031433133
• Company Name: NEXSCREEN, LLC
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com
• Phone: 1-888-956-8989
• Email: info@NexScreen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858984006330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

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: 2020-10-29
• Device Publish Date: 2020-10-21

Devices Manufactured by NEXSCREEN, LLC

• 00858984006330 - NexScreen Drug Screen Cup with AD: 2020-10-29AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(OX/pH/SG)/(GL/NI/CR)
• 00858984006330 - NexScreen Drug Screen Cup with AD: 2020-10-29 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(OX/pH/SG)/(GL/NI/CR)
• 00858984006347 - NexScreen Drug Screen Cup: 2020-10-29 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50
• 00858984006286 - NexScreen Drug Dip Card: 2019-12-19 NexScreen Drug Dip Card 5 Panel COC150/THC50/AMP500/OPI2000/PCP25
• 00858984006293 - NexScreen Drug Dip Card: 2019-12-19 NexScreen Drug Dip Card 9 Panel (6AM) 6AM10/AMP500/COC150/MDMA500/MET500/ MOR300/OXY100/PCP25/THC50
• 00858984006309 - NexScreen Drug Dip Card: 2019-12-19 NexScreen Drug Dip Card 9 Panel COC150/THC50/OPI2000/AMP500/MET500/ PCP25/BZO300/BAR300/MTD300
• 00858984006316 - NexScreen Drug Dip Card: 2019-12-19 NexScreen Drug Dip Card 9 Panel COC150/THC50/OPI2000/AMP500/MET500/ PCP25/BZO300/BAR300/MTD300
• 00858984006323 - NexScreen Drug Dip Card: 2019-12-19 NexScreen Drug Dip Card 12 Panel (PPX) BZO300/BAR300/COC150/THC50/MET500/OPI2000/ MTD300/OXY100/MDMA500/PCP25/AMP500/PPX300
• 00858984006279 - NexScreen Cup: 2019-09-09 CLIA-waived NexScreen Cup 12 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/ MTD300/OPI300/OXY100/PCP25/TCA1000/THC50