Duns Number:317134468
Device Description: The Measles Virus IgG ELISA is intended for the qualitative determination of IgG class ant The Measles Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Measles Virus in human serum or plasma (citrate, heparin).
Catalog Number
EIA-3844
Brand Name
Measles Virus IgG ELISA
Version/Model Number
EIA-3844
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
d2df876a-8dc8-48fc-9346-13d6675da695
Public Version Date
August 09, 2021
Public Version Number
3
DI Record Publish Date
June 05, 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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |