Rowley Biochemical Nuclear Fast Red Solution - Nuclear Fast Red Solution - TRANSENE COMPANY, INC.

Duns Number:044815983

Device Description: Nuclear Fast Red Solution

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More Product Details

Catalog Number

SO-130

Brand Name

Rowley Biochemical Nuclear Fast Red Solution

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

HZF

Product Code Name

Nuclear Fast Red

Device Record Status

Public Device Record Key

5e6e683e-f8b9-4c85-9632-25195fb59338

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