Duns Number:102855447
Device Description: Hematoxylin Counterstainer provides a nuclear blue counterstain for Immunocytochemical, Im Hematoxylin Counterstainer provides a nuclear blue counterstain for Immunocytochemical, Immunohistochemical and CISH procedures.
Catalog Number
BSB 0027
Brand Name
Hematoxylin Counterstainer
Version/Model Number
200 ml
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HYJ
Product Code Name
Hematoxylin
Public Device Record Key
cbebef05-4a25-4ca9-acac-3288082405e1
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 2020
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 | 3887 |