Duns Number:197934250
Device Description: For the quantitative determination of human IgM in serum by immunoturbidimetric assay.
Catalog Number
KAI-015
Brand Name
K-ASSAY® IgM Reagent
Version/Model Number
KAI-015
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
K993323
Product Code
CFF
Product Code Name
Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Public Device Record Key
7360343f-556f-4511-9568-9e4c1abc998b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 66 |