Duns Number:080953946
Device Description: The ZEUS AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System is a multiplex flow im The ZEUS AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System is a multiplex flow immunoassay intended for the qualitative detection of specific human IgG class antibodies to Treponema pallidum in human sera. The presence of antibodies to T. pallidum specific antigen, in conjunction with non treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. This test is for In Vitro diagnostic use only. This test is not intended for screening blood or plasma donors.
Catalog Number
A76101G
Brand Name
AtheNA Multi-Lyte® T. pallidum IgG Plus Test System
Version/Model Number
A76101G
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
4edfcf6d-b965-46a2-b4fd-e5b331662256
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 |