Duns Number:429572365
Device Description: Clin Chem Cal must be used only for the calibration of clinical chemistry tests. For in vi Clin Chem Cal must be used only for the calibration of clinical chemistry tests. For in vitro diagnostic use only.
Catalog Number
16550
Brand Name
Clin Chem Cal
Version/Model Number
16550
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070971
Product Code
JIX
Product Code Name
Calibrator, Multi-Analyte Mixture
Public Device Record Key
7c8d669a-3d83-4b1c-8899-039fef150ec1
Public Version Date
December 21, 2020
Public Version Number
4
DI Record Publish Date
June 29, 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |