Duns Number:044815983
Device Description: Chabot Schiff's Reagent for Histological Staining
Catalog Number
SO-1068
Brand Name
Rowley Biochemical Chabot Schiff's Reagent
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HZT
Product Code Name
Reagent, Schiff
Public Device Record Key
446740b5-c6be-47ec-b48e-19c346369a6a
Public Version Date
September 23, 2019
Public Version Number
1
DI Record Publish Date
September 13, 2019
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 | 58 |