FluoroMounter - FluoroMounter is an aqueous mounting media used - BIO SB, INC.

Duns Number:102855447

Device Description: FluoroMounter is an aqueous mounting media used for mounting cells or tissue sections stai FluoroMounter is an aqueous mounting media used for mounting cells or tissue sections stained by Immunofluorescence or FISH for the preservation of fluorescence staining.

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More Product Details

Catalog Number

BSB 0158

Brand Name

FluoroMounter

Version/Model Number

50 ml

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

PPM

Product Code Name

General Purpose Reagent

Device Record Status

Public Device Record Key

0ecabcbe-a64c-49cc-8b52-e090b1942a73

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO SB, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3887