AccessGUDID - DEVICE: BOND (05055331335388)

GUDID

Device Identifier (DI) Information

Brand Name: BOND
Version or Model: PA0708-U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PA0708-U
Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD

Primary DI Number: 05055331335388
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397134693 *Terms of Use

Device Description: Gross Cystic Disease Fluid Protein-15 (23A3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of (15 kD) human gross cystic disease fluid protein (GCDFP15) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).

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?
57255	Gross cystic disease fluid protein-15 IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of gross cystic disease fluid protein-15 (GCDFP-15), also known as BRST-2 antigen or prolactin-inducible protein (PIP), in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJT	Immunohistochemistry Reagents And Kits

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: ae8ed365-e907-4106-80fe-8ea17ac60bcf
Public Version Date: August 07, 2023
Public Version Number: 1
DI Record Publish Date: July 28, 2023