PreChek Multi-Drug Test Square Cup

GUDID 00857275007285

25 tests kit, 12 test items Cup; AMP-COC-OXY-THC-PCP-MDMA-MOP-BZO-BAR-MET-MTD-BUP

IDUN SOLUTIONS LLC

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Primary Device ID00857275007285
NIH Device Record Keye41bff07-8e72-45a2-86f4-3620b99ce997
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreChek Multi-Drug Test Square Cup
Version Model NumberIDOA-7325SC-25P
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 Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857275007094 [Package]
Package: Box [25 Units]
In Commercial Distribution
GS100857275007285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJREnzyme Immunoassay, Methadone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-11-08
Device Publish Date2018-06-20

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00857275007285 - PreChek Multi-Drug Test Square Cup2018-11-0825 tests kit, 12 test items Cup; AMP-COC-OXY-THC-PCP-MDMA-MOP-BZO-BAR-MET-MTD-BUP
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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