Duns Number:126544316
Device Description: An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocap An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
Catalog Number
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Brand Name
Nano-Check TM COVID-19 Antigen Test
Version/Model Number
MD-8147
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
49073bbf-ad92-44cf-886a-db1a2881beb5
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 18, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-