Duns Number:075150847
Device Description: For the qualitative determination of serum or plasma antibodies in humans, primarily IgG, For the qualitative determination of serum or plasma antibodies in humans, primarily IgG, to Schistosoma spp. using the ELISA technique.
Catalog Number
EIA-3512
Brand Name
Schistosoma IgG ELISA
Version/Model Number
EIA-3512
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
GNH
Product Code Name
ANTIGEN, FLUORESCENT ANTIBODY TEST, SCHISTOSOMA MANSONI
Public Device Record Key
68360723-c176-411d-9765-b735beaa9ce2
Public Version Date
June 15, 2021
Public Version Number
1
DI Record Publish Date
June 07, 2021
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 |