Duns Number:317134468
Device Description: Rheumatoid Factor IgM ELISA is a test system for the quantitative measurement of IgM class Rheumatoid Factor IgM ELISA is a test system for the quantitative measurement of IgM class rheumatoid factor in human serum or plasma.
Catalog Number
EIA-3585
Brand Name
Rheumatoid Factor IgM ELISA
Version/Model Number
EIA-3585
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
Yes
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
K100499
Product Code
DHR
Product Code Name
SYSTEM, TEST, RHEUMATOID FACTOR
Public Device Record Key
5a6f8412-e57b-45d7-b4d6-0e5c8d7fb505
Public Version Date
March 30, 2020
Public Version Number
2
DI Record Publish Date
June 10, 2019
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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |