Duns Number:341714388
Device Description: AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and qualitative AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex highly purified from the cell-line HeLa. The U1-snRNP complex comprises the Smith antigen (Sm) and RNPs, the 70kDa U1specific protein plus protein A and C. The assay is a tool for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE)
Catalog Number
-
Brand Name
AESKULISA® snRNP-C
Version/Model Number
3105
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 27, 2017
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LJM
Product Code Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Public Device Record Key
d4ee7afe-8d64-454d-aef2-26c80b566f47
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 27, 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. | 77 |