PathoCatch MPF25

GUDID 08908016644015

COVID-19 Antigen Fluorescence Immunoassay Kit

MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED

SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay, rapid
Primary Device ID08908016644015
NIH Device Record Key7209a59a-8964-4b0c-bc1e-97aed60e469e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePathoCatch
Version Model NumberMPF25
Catalog NumberMPF25
Company DUNS860396703
Company NameMYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108908016644015 [Primary]

FDA Product Code

QKPCoronavirus Antigen Detection Test System.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-21
Device Publish Date2021-10-13

Devices Manufactured by MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED

08908016644039 - CoviSelf2022-03-22 COVID-19 Antigen Lateral Flow Test Device.
08908016644008 - CoviSelf2021-11-19 COVID-19 Antigen Lateral Flow Test Device.
08908016644022 - Gazelle PathoCatch2021-11-17 COVID-19 Antigen Fluorescence Immunoassay Kit
08908016644015 - PathoCatch2021-10-21COVID-19 Antigen Fluorescence Immunoassay Kit
08908016644015 - PathoCatch2021-10-21 COVID-19 Antigen Fluorescence Immunoassay Kit

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