Duns Number:429572365
Device Description: Immuno Control Set is for use in quality control by monitoring accuracy and precision for Immuno Control Set 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 professional use only. For In Vitro diagnostic use.
Catalog Number
11211A
Brand Name
Immuno Control Set
Version/Model Number
11211A
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
e84862e8-f8d8-4165-898c-d0af2cb448b7
Public Version Date
February 25, 2020
Public Version Number
2
DI Record Publish Date
November 15, 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |