OPI/COC/THC Tests Panel

GUDID 06952804801946

ASSURE TECH. (HANGZHOU) CO., LTD.

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Primary Device ID06952804801946
NIH Device Record Key4af631d0-cae4-4a7a-972b-5d9460ea4fc8
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPI/COC/THC Tests Panel
Version Model Number1.0
Company DUNS530757741
Company NameASSURE TECH. (HANGZHOU) CO., LTD.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106952804801946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFYTest, Cocaine And Cocaine Metabolites, Over The Counter

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 Date2017-08-18

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