Duns Number:045361136
Device Description: The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system intended The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system intended for use on the Sirrus® Chemistry Analyzer to calibrate the ISE module option for chloride, potassium and sodium.
Catalog Number
20270477
Brand Name
Sirrus® ISE Calibrator 1
Version/Model Number
20270477
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
JIX
Product Code Name
Calibrator, Multi-Analyte Mixture
Public Device Record Key
85522456-3825-4aef-9961-9cbe12958bf5
Public Version Date
December 21, 2020
Public Version Number
3
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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |