Fastep COVID-19 IgG/IgM Rapid Test Device

GUDID 06952804805029

ASSURE TECH. (HANGZHOU) CO., LTD.

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Primary Device ID06952804805029
NIH Device Record Key8d67728e-0416-439a-9093-95b33c4329f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameFastep COVID-19 IgG/IgM Rapid Test Device
Version Model Number1.0
Company DUNS530757741
Company NameASSURE TECH. (HANGZHOU) CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS106952804805029 [Primary]

FDA Product Code

QKOReagent, Coronavirus Serological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-27
Device Publish Date2021-01-19

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

06952804805029 - Fastep COVID-19 IgG/IgM Rapid Test Device2021-01-27
06952804805029 - Fastep COVID-19 IgG/IgM Rapid Test Device2021-01-27
06952804830212 - AssureTech Panel Dip Tests2018-10-08 AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, PCP25, MTD300, EDDP300, TCA1000, PPX300
06952804830229 - AssureTech Quick Cup Tests2018-10-08
06952804802608 - AssureTech Panel Dip Tests2018-10-05 15 Strips, including MOR300
06952804802615 - AssureTech Quick Cup Tests2018-10-05 15 strips, including MOR300
06952804802622 - AssureTech Panel Dip Tests2018-10-05 15 strips, including MOR2000
06952804802639 - AssureTech Quick Cup Tests2018-10-05 15 strips, including MOR2000
06952804801083 - Panel Dip2018-07-06
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