Duns Number:102855447
Device Description: Fast ChromoProtector is used in histological, immunohistochemical and in situ hybridizatio Fast ChromoProtector is used in histological, immunohistochemical and in situ hybridization staining procedures to preserve stains before the permanent mounting of tissues or cell preparations
Catalog Number
BSB-0327-1000
Brand Name
Fast ChromoProtector
Version/Model Number
1000 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
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
796e9cac-04b7-4d04-a2f4-bbf53c820b16
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 |