Duns Number:080953946
Device Description: The ZEUS IFA Toxoplasma gondii IgM Test System is an indirect fluorescent antibody assay d The ZEUS IFA Toxoplasma gondii IgM Test System is an indirect fluorescent antibody assay designed for the presumptive qualitative detection of IgM antibodies to T. gondii in human serum and for the presumptive diagnosis of acute, recent, or reactive T. gondii infection. To adquately assess the patient’s serological status; testing must be performed in conjunction with an anti-T. gondii IgG antibody assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. Performance characteristics have not been established for screening sera from prenatal women or newborns.
Catalog Number
FA8001M
Brand Name
IFA T. gondii IgM Test System
Version/Model Number
FA8001M
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
-
Product Code Name
-
Public Device Record Key
fe3c2ab2-5bff-49c2-8e55-c413e4e5ecfb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |