Duns Number:397134693
Device Description: The Novocastra™ Epitope Retrieval Solutions RE7113, RE7114, RE7116 and RE7119 are intended The Novocastra™ Epitope Retrieval Solutions RE7113, RE7114, RE7116 and RE7119 are intended for Heat Induced Epitope Retrieval on formalin-fixed, paraffin-embedded tissue sections as part of an immunohistochemical procedure.
Catalog Number
RE7113
Brand Name
Novocastra™
Version/Model Number
RE7113-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
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
efca6a98-1ca7-4857-b097-6004142e9d95
Public Version Date
March 22, 2021
Public Version Number
1
DI Record Publish Date
March 12, 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 |