Duns Number:317134468
Device Description: ANA Combi ELISA is a test system for the qualitative measurement of ANA autoantibodies dir ANA Combi ELISA is a test system for the qualitative measurement of ANA autoantibodies directed against RNP-70, RNP/Sm, Sm, SS-A (52 and 60 kDa), SS-B, Scl-70, Centromere B and Jo-1 in human serum or plasma.
Catalog Number
EIA-3563
Brand Name
ANA Combi (ANA-8-Profile) ELISA
Version/Model Number
EIA-3563
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
K030929
Product Code
LJM
Product Code Name
ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS
Public Device Record Key
69d24f2e-abae-4405-9a09-571978be8bbe
Public Version Date
March 30, 2020
Public Version Number
2
DI Record Publish Date
June 10, 2019
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 | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |