Duns Number:044815983
Device Description: Lillie's Crystal Violet Solution
Catalog Number
SO-500
Brand Name
Rowley Biochemical Crystal Violet, Lillie's
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
ICF
Product Code Name
Crystal Violet For Histology
Public Device Record Key
c3f84f8a-564d-47d8-81ff-761f87423f54
Public Version Date
September 24, 2019
Public Version Number
1
DI Record Publish Date
September 16, 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 |