Duns Number:487811143
Device Description: The Fasciola hepatica ELISA test is a qualitative enzyme immunoassay for the detection of The Fasciola hepatica ELISA test is a qualitative enzyme immunoassay for the detection of Fasciola hepatica antibodies in human serum samples.
Catalog Number
9650
Brand Name
Fasciola hepatica IgG ELISA
Version/Model Number
9650
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KHW
Product Code Name
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Public Device Record Key
8e182404-e296-45f1-8202-d58dc442ecbc
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 2022
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |