Duns Number:328133103
Device Description: Rheumatoid Factor IgG is an ELISA test system for the quantitative measurement of IgG clas Rheumatoid Factor IgG is an ELISA test system for the quantitative measurement of IgG class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.
Catalog Number
ORG522G
Brand Name
RHEUMATOID FACTOR IgG
Version/Model Number
ORG522G
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
-
Product Code
DHR
Product Code Name
System, Test, Rheumatoid Factor
Public Device Record Key
f3122340-b330-421e-94de-c82647fc6114
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 21 |