Duns Number:052423787
Device Description: The Nanoduct Neonatal Sweat Analysis System is intended for laboratory use by qualified pe The Nanoduct Neonatal Sweat Analysis System is intended for laboratory use by qualified personnel to provide laboratory confirmation of a clinical diagnosis of cystic fibrosis.
Catalog Number
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Brand Name
Nanoduct Neonatal Sweat Analysis System
Version/Model Number
Nanoduct Sys 1030
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
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Prescription Use (Rx)
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Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
K010031
Product Code
KTB
Product Code Name
Device, Iontophoresis, Specific Uses
Public Device Record Key
853c9eea-c9fc-48ed-bdd8-5b000ffb5fd5
Public Version Date
February 22, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |