Duns Number:487811143
Device Description: The Entamoeba histolytica ELISA test is a qualitative enzyme immunoassay for the detection The Entamoeba histolytica ELISA test is a qualitative enzyme immunoassay for the detection of Entamoeba histolytica antibodies in human serum samples.
Catalog Number
9550
Brand Name
Entamoeba histolytica IgG ELISA
Version/Model Number
9550
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
e22c641a-d0d0-4a86-a7ea-2761c4ef8cb5
Public Version Date
August 17, 2022
Public Version Number
1
DI Record Publish Date
August 09, 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 |