Duns Number:790524891
Device Description: ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies against S ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies against Scl-70 in human serum as an aid in the diagnosis of autoimmune disease.
Catalog Number
720-280
Brand Name
Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit
Version/Model Number
720-280
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Product Code
LLL
Product Code Name
Extractable Antinuclear Antibody, Antigen And Control
Public Device Record Key
57c39795-8041-479a-8253-d142b5bb5dbf
Public Version Date
June 04, 2021
Public Version Number
2
DI Record Publish Date
July 27, 2020
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |