Duns Number:940425333
Device Description: Substitute Serum Control D for specimen. Otherwise follow the Procedure as described in th Substitute Serum Control D for specimen. Otherwise follow the Procedure as described in the ImmunoDOT Autoimmunity Test package insert.
Catalog Number
3918
Brand Name
ImmunoDOT Serum Control D
Version/Model Number
800-3918
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
K896347
Product Code
LJM
Product Code Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Public Device Record Key
0df9c1e6-e513-4d26-acb1-61b019230b6a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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. | 32 |