Oxycodone Strip

GUDID 06952804801113

ASSURE TECH. (HANGZHOU) CO., LTD.

Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT)
Primary Device ID06952804801113
NIH Device Record Keyc238fc39-d065-4bea-b931-4600e2d93082
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxycodone Strip
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 Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106952804801113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates

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 Date2017-02-04

Devices Manufactured by ASSURE TECH. (HANGZHOU) CO., LTD.

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