AccessGUDID - DEVICE: BOND-PRIME (05055331330550)

GUDID

Device Identifier (DI) Information

Brand Name: BOND-PRIME
Version or Model: AR0096
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AR0096
Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD

Primary DI Number: 05055331330550
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397134693 *Terms of Use

Device Description: BOND-PRIME Hematoxylin is a ready to use reagent that facilitates cell nuclei (blue) counterstaining of formalin-fixed, paraffinembedded tissue in immunohistochemistry (IHC) and in situ hybridization (ISH) using the automated BOND-PRIME staining system

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
43606	Differentiation solution IVD	A differentiation solution intended to be used alone, or in combination with other solutions/stains, for the visualization of biological/clinical specimen tissue structures and/or intra/extracellular elements.	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5bce8a7b-f524-40a0-8346-93725117a1d3
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022