Duns Number:328133103
Device Description: Anti-MCV® is an ELISA test system for the qualitative and semi-quantitative measurement of Anti-MCV® is an ELISA test system for the qualitative and semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma. This product is intended for professional in vitro diagnostic use as an aid in the diagnosis of Rheumatoid Arthritis in conjuction with other laboratory and clinical findings.
Catalog Number
ORG548
Brand Name
ANTI-MCV
Version/Model Number
ORG548
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
OQZ
Product Code Name
Anti-Mutated Citrullinated Vimentin Igg
Public Device Record Key
d1db33b2-8021-4ce3-8269-25ce72c7afa6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 08, 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 |