Duns Number:052423787
Device Description: ELITechGroup Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a ELITechGroup Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of validating the measurement of conductivity , osmolality, or chloride in patient samples.
Catalog Number
-
Brand Name
Sweat Controls, L1, L2, L3, 12 ea., 36x0.75mL
Version/Model Number
SS-150
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"
-
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
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
35947a09-66d3-4b1c-a4fa-baff43502b52
Public Version Date
October 26, 2020
Public Version Number
1
DI Record Publish Date
October 16, 2020
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 |