Amphetamine Panel Dip

GUDID 06952804801748

ASSURE TECH. (HANGZHOU) CO., LTD.

Amphetamine-specific IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID06952804801748
NIH Device Record Key2eb2348a-4ad4-47f8-bd41-e97489147a6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmphetamine Panel Dip
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106952804801748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

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 Date2017-07-24

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

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06952804830229 - AssureTech Quick Cup Tests2018-10-08
06952804802608 - AssureTech Panel Dip Tests2018-10-05 15 Strips, including MOR300
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06952804802622 - AssureTech Panel Dip Tests2018-10-05 15 strips, including MOR2000
06952804802639 - AssureTech Quick Cup Tests2018-10-05 15 strips, including MOR2000
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