Duns Number:080953946
Device Description: The ZEUS ELISA Sm/RNP Test System is a semi-quantitative immunoassay for the detection of The ZEUS ELISA Sm/RNP Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm/RNP in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. This device is for In Vitro diagnostic use.
Catalog Number
2Z2841G
Brand Name
ELISA Sm/RNP Test System
Version/Model Number
2Z2841G
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
d5f15de7-9fc0-435d-a80f-c9cd1dbc95c9
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 |