QuikScreen 13+4 Drug Cup Test

GUDID 20748349000032

QuikScreen 13+4 (pouch cup): AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, MDMA 500, OPI 300, OXY 100, PCP 25, THC 50 + pH/CRE/SG/GTA

SYNTRON BIORESEARCH, INC.

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Primary Device ID20748349000032
NIH Device Record Key84c7f027-09b0-42ae-b03f-72a5f243f40e
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuikScreen 13+4 Drug Cup Test
Version Model Number65D03-17
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
GS100748349000038 [Primary]
GS110748349000035 [Package]
Contains: 00748349000038
Package: Kit Box [25 Units]
In Commercial Distribution
GS120748349000032 [Package]
Contains: 10748349000035
Package: Shipper Box [4 Units]
In Commercial Distribution

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-09-27

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