Duns Number:341714388
Device Description: AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing C AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum.
Catalog Number
-
Brand Name
AESKUSLIDES nDNA (Crithidia luciliae)
Version/Model Number
53.100.US
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172348
Product Code
LSW
Product Code Name
Anti-Dna Antibody, Antigen And Control
Public Device Record Key
78b592c6-aecb-4ad6-9e3f-add901736a7a
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 14, 2018
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 |