Duns Number:126544316
Device Description: A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SA A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.
Catalog Number
-
Brand Name
Nano-CheckTM COVID-19 IgG/IgM Antibody Test
Version/Model Number
MD8145
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)
-
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
38899c11-c8db-46bd-993b-c54e7eb35130
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 10, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-