Duns Number:080953946
Device Description: The ZEUS ELISA ANA Screen Test System is a qualitative screening assay designed to detect The ZEUS ELISA ANA Screen Test System is a qualitative screening assay designed to detect anti-nuclear antibodies (ANA) in human sera. When performed according to these instructions, this test system is capable of detecting all ANAs commonly tested for, such as those against double stranded DNA (dsDNA), Jo-1, Sm, Sm/RNP, SSA, SSB, and Scl-70. The test is also capable of detecting ANA demonstrating centromere, nucleolar, peripheral, and spindle indirect immunofluorescence antibody (IFA) patterns. This test is for In Vitro diagnostic use.
Catalog Number
2Z29001G
Brand Name
ELISA ANA Screen Test System
Version/Model Number
2Z29001G
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
babda822-0829-4a24-9ee8-daa214331c4a
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 |