Duns Number:317134468
Device Description: The Measles Virus IgG Avidity ELISA is intended to indicate the Measles-specific IgG avidi The Measles Virus IgG Avidity ELISA is intended to indicate the Measles-specific IgG avidity in human serum or plasma (citrate, heparin) to differentiate between acute and past infection.
Catalog Number
EIA-5967
Brand Name
Measles Virus IgG Avidity ELISA
Version/Model Number
EIA-5967
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
LJB
Product Code Name
Enzyme linked immunoabsorbent assay, rubeola IgG
Public Device Record Key
bc53a78d-53f2-4e64-b99d-a0610132cf7d
Public Version Date
August 09, 2021
Public Version Number
2
DI Record Publish Date
June 07, 2021
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 |