Duns Number:102855447
Device Description: The Bio SB Automated TintoStainer is an automated 36, 48, or 72 slide system for use in Im The Bio SB Automated TintoStainer is an automated 36, 48, or 72 slide system for use in Immunohistochemistry (IHC) and Immunocytochemistry (ICC). The TintoStainer is perfect for laboratories that have a need increase work-flow efficiency through automation, yet want to maintain low operating costs. The TintoStainer is a rapid, flexible, open and affordable solution which allows for fast implementation of laboratory protocols while keeping a compact footprint.
Catalog Number
BSB 7029
Brand Name
TintoStainer 36 Slide (110V) with Report Printer + UPS
Version/Model Number
TintoStainer 36 (110V)
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
KPA
Product Code Name
Slide Stainer, Automated
Public Device Record Key
23ee9000-7993-4e73-a8e6-cefb6d7e0db3
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 |