Duns Number:197934250
Device Description: For the quantitative determination of human beta-2 microglobulin in serum/plasma or urine For the quantitative determination of human beta-2 microglobulin in serum/plasma or urine by immunoturbidimetric assay.
Catalog Number
KAI-280
Brand Name
K-ASSAY® Beta-2 Microglobulin Reagent
Version/Model Number
KAI-280
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
JZG
Product Code Name
System, Test, Beta-2-Microglobulin Immunological
Public Device Record Key
643b8e57-9a0d-4d22-a920-90d437449fdb
Public Version Date
October 10, 2022
Public Version Number
2
DI Record Publish Date
December 19, 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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 66 |