Duns Number:080953946
Device Description: The ZEUS IFA Anti-Mitochondrial Antibody (AMA) Test System is designed for the qualitative The ZEUS IFA Anti-Mitochondrial Antibody (AMA) Test System is designed for the qualitative and semi-quantitative detection of Mitochondrial Antibodies (MA) by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use.
Catalog Number
FA3001
Brand Name
IFA AMA Test System
Version/Model Number
FA3001
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
4339bebd-5608-4d71-89e1-cb075d61f8a6
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 |