Duns Number:126544316
Device Description: A lateral flow immunoassay for the qualitative detection of Strep A specific carbohydrate A lateral flow immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from human throat swabs specimen collected from symptomatic patients to aid in the diagnosis of Group A Streptococcal infection
Catalog Number
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Brand Name
Nano-Check TM Strep A Test
Version/Model Number
MD8148
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)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
bbcda0c2-c5f5-42fa-bcdc-6db43ebeecd5
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 15, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-