Duns Number:080953946
Device Description: The ZEUS IFA Toxoplasma gondii IgG Test System is designed to detect the presence of circu The ZEUS IFA Toxoplasma gondii IgG Test System is designed to detect the presence of circulating T. gondii antibodies in human sera and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.
Catalog Number
FA8001G
Brand Name
IFA T. gondii IgG Test System
Version/Model Number
FA8001G
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
c27bffdb-88f2-43ae-8e86-f129ffa36676
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 |