CoviSelf MDSC01

GUDID 08908016644008

COVID-19 Antigen Lateral Flow Test Device.

MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED

SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Primary Device ID08908016644008
NIH Device Record Key819006f3-08df-44a1-a524-be9a612bf073
Commercial Distribution Discontinuation2030-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoviSelf
Version Model NumberMDSC01
Catalog NumberMDSC01
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com
Phone(844) 793-2020
Emailsupport@2020dx.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS108908016644008 [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 Date2021-11-19
Device Publish Date2021-11-11

On-Brand Devices [CoviSelf]

08908016644008COVID-19 Antigen Lateral Flow Test Device.
08908016644039COVID-19 Antigen Lateral Flow Test Device.

Trademark Results [CoviSelf]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COVISELF
COVISELF
97418168 not registered Live/Pending
MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED
2022-05-19

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