Duns Number:117458512
Device Description: The United States (US) Food and Drug Administration (FDA) has issued an Emergency UseAutho The United States (US) Food and Drug Administration (FDA) has issued an Emergency UseAuthorization (EUA) to authorize the use of the Zika ELITe MGB® Kit U.S. for the in vitroqualitative detection of Zika virus with specified instruments. This assay tests for Zika virusRNA in human serum and EDTA plasma.
Catalog Number
M800552
Brand Name
Zika ELITe MGB® - EUA
Version/Model Number
M800552
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
-
Product Code Name
-
Public Device Record Key
a69bb12c-33eb-4c0c-a5b5-df4520ac332c
Public Version Date
October 15, 2020
Public Version Number
2
DI Record Publish Date
September 08, 2020
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 | 106 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |