Duns Number:429572365
Device Description: Clin Chem Control 2 is for use in quality control by monitoring accuracy and precision for Clin Chem Control 2 is for use in quality control by monitoring accuracy and precision for the quantitative method as specified in the assigned concentration Table. Use the Control Material like the specimens, according to the indicated analytical procedure. For In Vitro Diagnostic use.
Catalog Number
16250
Brand Name
Clin Chem Control 2
Version/Model Number
16250
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
-
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
f68869c5-1f60-4721-8caa-1f874eae0de1
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
March 18, 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |