Duns Number:075150847
Device Description: The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of ant The E. histolytica ELISA test is a qualitative enzyme immunoassay for the detection of antibodies to E. histolytica, in samples of human serum or plasma.
Catalog Number
EIA-3474
Brand Name
E. Histolytica IgG ELISA
Version/Model Number
EIA-3474
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"
Yes
For Single-Use
-
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
927a36a2-859d-4ccb-908c-9d3e267c8b7b
Public Version Date
March 30, 2020
Public Version Number
2
DI Record Publish Date
March 20, 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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |