AccessGUDID - DEVICE: FluoroMounter with DAPI (B502BSB01630)

GUDID

Device Identifier (DI) Information

Brand Name: FluoroMounter with DAPI
Version or Model: 15 ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 0163
Company Name: BIO SB, INC.

Primary DI Number: B502BSB01630
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: FluoroMounter with DAPI is an aqueous mounting media used for counterstaining cells or tissues stained by Immunofluorescence or FISH with DAPI while preserving the fluorescent staining.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62512	DAPI solution IVD	A solution containing the fluorescent dye 4',6-Diamidino-2-phenylindole dihydrochloride (DAPI) intended to be used as a counterstain for the visualization of deoxyribonucleic acids (DNA) in assays performed on biological tissues or clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f9c0545-d1ed-4963-acdf-adbd59c3cbe9
Public Version Date: October 08, 2020
Public Version Number: 1
DI Record Publish Date: September 30, 2020