Duns Number:784143778
Device Description: The ENA-6Pro ELISA is a solid phase enzyme immunoassay for the separate semiquantitative d The ENA-6Pro ELISA is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.
Catalog Number
35-E6PHU-E01
Brand Name
ENA-6Pro ELISA
Version/Model Number
35-E6PHU-E01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 01, 2019
Issuing Agency
In HIBCC
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
K032469
Product Code
LJM
Product Code Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Public Device Record Key
11a34958-36ea-4a82-a940-f6c349d5d41d
Public Version Date
September 20, 2022
Public Version Number
5
DI Record Publish Date
August 28, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |