CoviSelf MDSC02
GUDID 08908016644039
COVID-19 Antigen Lateral Flow Test Device.
MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED
SARS-CoV-2 antigen IVD, kit, immunochromatographic test (ICT), self-testing| Primary Device ID | 08908016644039 |
| NIH Device Record Key | 83ac7d3b-23ca-4fbb-b0f0-fa546c6eb1d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoviSelf |
| Version Model Number | MDSC02 |
| Catalog Number | MDSC02 |
| Company DUNS | 860396703 |
| Company Name | MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com | |
| Phone | (844) 793-2020 |
| support@2020dx.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08908016644039 [Primary] |
| GS1 | 08908016644060 [Package] Package: Boxed [4 Units] In Commercial Distribution |
FDA Product Code
| QKP | Coronavirus Antigen Detection Test System. |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-22 |
| Device Publish Date | 2022-03-14 |
On-Brand Devices [CoviSelf]
| 08908016644008 | COVID-19 Antigen Lateral Flow Test Device. |
| 08908016644039 | COVID-19 Antigen Lateral Flow Test Device. |
Trademark Results [CoviSelf]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COVISELF 97418168 not registered Live/Pending |
MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED 2022-05-19 |
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