PreChek

GUDID 00857275007421

12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300• BZO300• BAR300•MET1000• MTD300•BUP10)

IDUN SOLUTIONS LLC

Buprenorphine IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00857275007421
NIH Device Record Key100fae57-ff25-4998-a322-1c5118aefcd8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreChek
Version Model Number21512050010308
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 Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100857275007421 [Package]
Contains: 00857275007520
Package: [25 Units]
In Commercial Distribution
GS100857275007520 [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 Date2018-08-02

On-Brand Devices [PreChek]

0085727500711712 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300•
0085727500742112 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300•

Trademark Results [PreChek]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRECHEK
PRECHEK
87501960 5591273 Live/Registered
iDun Solutions, LLC
2017-06-22

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