Duns Number:197934250
Device Description: For the quantitative determination of human rheumatoid factor (RF) in serum by immunoturbi For the quantitative determination of human rheumatoid factor (RF) in serum by immunoturbidimetric assay.
Catalog Number
KAI-031
Brand Name
K-ASSAY® RF Reagent
Version/Model Number
KAI-031
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 18, 2021
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
K991409
Product Code
DHR
Product Code Name
System, Test, Rheumatoid Factor
Public Device Record Key
641c363e-6d5d-44fd-a0f3-630380ac5a60
Public Version Date
June 21, 2021
Public Version Number
4
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 |