Duns Number:397134693
Device Description: NCL-L-SYNAP-299 is intended for the qualitative identification by light microscopy of Syna NCL-L-SYNAP-299 is intended for the qualitative identification by light microscopy of Synaptophysin molecules in paraffin sections.
Catalog Number
NCL-L-SYNAP-299
Brand Name
Novocastra™
Version/Model Number
SYNAP-299-L-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
31881984-a663-4b02-9e17-a18abdd9f960
Public Version Date
May 10, 2021
Public Version Number
1
DI Record Publish Date
April 30, 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 |