QuikScreen 5 Drug Cup Test

GUDID 20748349000056

QuikScreen 5: AMP 1000, COC 300, OPI 2000, PCP 25, THC 50

SYNTRON BIORESEARCH, INC.

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Primary Device ID20748349000056
NIH Device Record Key1e6efa61-2df7-459a-9cf9-50acb27183ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuikScreen 5 Drug Cup Test
Version Model Number60505
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
GS100748349000052 [Primary]
GS110748349000059 [Package]
Contains: 00748349000052
Package: Kit Box [25 Units]
In Commercial Distribution
GS120748349000056 [Package]
Contains: 10748349000059
Package: Shipper Box [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCMEnzyme Immunoassay, Phencyclidine

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 Date2016-09-27

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