Rowley Biochemical Crystal Violet, Certified - Crystal Violet, BSC Certified - TRANSENE COMPANY, INC.

Duns Number:044815983

Device Description: Crystal Violet, BSC Certified

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

R-36

Brand Name

Rowley Biochemical Crystal Violet, Certified

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

ICF

Product Code Name

Crystal Violet For Histology

Device Record Status

Public Device Record Key

7c141a1b-279c-45a0-a127-674f0fd26a4d

Public Version Date

September 24, 2019

Public Version Number

1

DI Record Publish Date

September 16, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRANSENE COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58