Duns Number:010558476
Device Description: 96 well ELISA for the detection of IgA Rheumatoid Factor antibodies in human serum.
Catalog Number
FGA06
Brand Name
Autostat II IgA Rheumatoid Factor
Version/Model Number
FGA06
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
K993557
Product Code
DHR
Product Code Name
System, Test, Rheumatoid Factor
Public Device Record Key
a73a28a1-da77-49d0-b13b-33bbedc80b62
Public Version Date
September 17, 2018
Public Version Number
1
DI Record Publish Date
August 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 | 158 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 148 |