Duns Number:276816717
Device Description: VIDAS Measles IgG (MSG) assay is a quantitative IA intended for use on VIDAS family instru VIDAS Measles IgG (MSG) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to measles (rubeola) in human serum.
Catalog Number
-
Brand Name
VIDAS® Measles IgG
Version/Model Number
30219
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
-
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
LJB
Product Code Name
Enzyme linked immunoabsorbent assay, rubeola IgG
Public Device Record Key
0c8e2c48-f22a-4fc6-8529-e77fbbe6f098
Public Version Date
September 09, 2019
Public Version Number
1
DI Record Publish Date
August 30, 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |