Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards)

GUDID 00857275007124

15 THC test dip-cards

IDUN SOLUTIONS LLC

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00857275007124
NIH Device Record Key9de048b1-35b6-4b2e-b660-2c643c2b0fb9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreknow THC (Marijuana) Single Drug Screen Test (15 Dipcards)
Version Model NumberIDTH-115-15P
Company DUNS080651010
Company NameIDUN SOLUTIONS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100857275007025 [Package]
Package: 15 THC test dipcards [15 Units]
In Commercial Distribution
GS100857275007124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-16

Devices Manufactured by IDUN SOLUTIONS LLC

90857275007837 - Wholepower2022-06-10 10-Panel Urine Dip Panel (MET/MOP/OXY/AMP/BZO/BAR/COC/PCP/MDMA/BUP)
90857275007813 - N/M2021-05-24 25-pack 10 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/ BAR/BZO/MTD/OXY)
00857275007797 - N/M2019-09-03 12 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/BAR/BZO/MTD/MDMA/OXY/BUP)
00857275007070 - PreKnow2018-12-31 PreKnow 5-Panel Instant Multi-Drug Screen Test Dip Card, THC-COC-OPI-AMP-PCP
00857275007261 - PreKnow2018-12-31 PreKnow Instant 10 Panel Multi-Drug Test DipCard (BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-TCA-THC)
00857275007735 - PreKnow2018-11-15 HCG Pregnancy Test Strip-3.5mm
00857275007063 - PreChek Multi-Drug Test Cup2018-11-08 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 Cup2018-11-08 25 tests kit, 12 test items Cup; AMP-COC-OXY-THC-PCP-MDMA-MOP-BZO-BAR-MET-MTD-BUP

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