PreChek Multi-Drug Test Cup

GUDID 00857275007063

5 tests kit, 12 test items Cup; AMP/COC/OXY/THC/PCP/MDMA/MOP/BZO/BAR/MET/MTD/TCA

IDUN SOLUTIONS LLC

Tricyclic antidepressant IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00857275007063
• NIH Device Record Key: 085d82b8-f542-45cd-9a36-9636c47952dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreChek Multi-Drug Test Cup
• Version Model Number: IDOA-7225RC-5P
• Company DUNS: 080651010
• Company Name: IDUN SOLUTIONS 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857275007063 [Package]; Contains: 00857275007162; Package: poly bag [5 Units]; In Commercial Distribution
GS1	00857275007162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153050

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: 2
• Public Version Date: 2018-11-08
• Device Publish Date: 2018-06-20

Devices Manufactured by IDUN SOLUTIONS LLC

• 90857275007837 - Wholepower: 2022-06-10 10-Panel Urine Dip Panel (MET/MOP/OXY/AMP/BZO/BAR/COC/PCP/MDMA/BUP)
• 90857275007813 - N/M: 2021-05-24 25-pack 10 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/ BAR/BZO/MTD/OXY)
• 00857275007797 - N/M: 2019-09-03 12 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/BAR/BZO/MTD/MDMA/OXY/BUP)
• 00857275007070 - PreKnow: 2018-12-31 PreKnow 5-Panel Instant Multi-Drug Screen Test Dip Card, THC-COC-OPI-AMP-PCP
• 00857275007261 - PreKnow: 2018-12-31 PreKnow Instant 10 Panel Multi-Drug Test DipCard (BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-TCA-THC)
• 00857275007735 - PreKnow: 2018-11-15 HCG Pregnancy Test Strip-3.5mm
• 00857275007063 - PreChek Multi-Drug Test Cup: 2018-11-085 tests kit, 12 test items Cup; AMP/COC/OXY/THC/PCP/MDMA/MOP/BZO/BAR/MET/MTD/TCA
• 00857275007063 - PreChek Multi-Drug Test Cup: 2018-11-08 5 tests kit, 12 test items Cup; AMP/COC/OXY/THC/PCP/MDMA/MOP/BZO/BAR/MET/MTD/TCA
• 00857275007285 - PreChek Multi-Drug Test Square Cup: 2018-11-08 25 tests kit, 12 test items Cup; AMP-COC-OXY-THC-PCP-MDMA-MOP-BZO-BAR-MET-MTD-BUP