Duns Number:010717890
Device Description: The Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of The Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of monitoring the measurement of conductivity and osmolality by cystic fibrosis screening procedures and to validate the analysis of Chloride, Potassium, and Sodium by confirmatory methods used to quantitate patient samples. They are liquid, ready-to-use, requiring no reconstitution or dilution. They are supplied in three levels, nine vials per box, 3x3mL each level. They are prepared in an aqueous simulated human sweat matrix to which preservatives have been added.
Catalog Number
1190-01
Brand Name
Sweat Control Level 1, 2, & 3 Set 9x3mL
Version/Model Number
1190-01
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K943925
Product Code
JJR
Product Code Name
Electrolyte Controls (Assayed And Unassayed)
Public Device Record Key
fe4abe4c-64c8-46dc-9242-581dfd45bdd2
Public Version Date
October 29, 2018
Public Version Number
1
DI Record Publish Date
September 26, 2018
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |