Duns Number:397134693
Device Description: Novolink™ Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM Novolink™ Polymer Detection Systems are used for the visualization of mouse IgG, mouse IgM and rabbit IgG primary antibodies. Novolink™ Polymer and Novolink™ DAB (Polymer) contain component reagents of these systems and are intended for use in the procedure described below.
Catalog Number
RE7140-K
Brand Name
Novolink™
Version/Model Number
RE7140-CE
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
-
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
NJT
Product Code Name
Immunohistochemistry Reagents And Kits
Public Device Record Key
1159d222-32de-4124-a9ce-6d9322c91d09
Public Version Date
April 26, 2021
Public Version Number
1
DI Record Publish Date
April 16, 2021
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 | 365 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| 3 | A medical device with high risk that requires premarket approval | 1 |