Duns Number:397134693
Device Description: NCL-L-TTF-1 is intended for the qualitative identification by light microscopy of Thyroid NCL-L-TTF-1 is intended for the qualitative identification by light microscopy of Thyroid Transcription Factor-1 in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist
Catalog Number
NCL-L-TTF-1
Brand Name
Novocastra™
Version/Model Number
TTF-1-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
787a467e-52e8-4fa2-993e-4f2d6fc8ec36
Public Version Date
April 19, 2021
Public Version Number
1
DI Record Publish Date
April 09, 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 |