QuikScreen 7+4

GUDID 00748349000724

QuikScreen 7+4 AMP 500, COC 150, MDMA 500, MET 500, OPI 2000, OXY 100, THC50 + PH/CRE/SG/NBP Cat. 65732-7

SYNTRON BIORESEARCH, INC.

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Primary Device ID00748349000724
NIH Device Record Key81625b7d-e3b5-4572-888a-dd1af3495a64
Commercial Distribution Discontinuation2020-09-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameQuikScreen 7+4
Version Model Number65732-7
Company DUNS174517060
Company NameSYNTRON BIORESEARCH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100748349000724 [Primary]
GS110748349000721 [Package]
Package: Kit Box [25 Units]
Discontinued: 2020-09-28
Not in Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-06
Device Publish Date2020-09-28

Devices Manufactured by SYNTRON BIORESEARCH, INC.

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00748349000724 - QuikScreen 7+42020-10-06 QuikScreen 7+4 AMP 500, COC 150, MDMA 500, MET 500, OPI 2000, OXY 100, THC50 + PH/CRE/SG/NBP Cat. 65732-7
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