AccessGUDID - DEVICE: BOND™ (05055331328335)

GUDID

Device Identifier (DI) Information

Brand Name: BOND™
Version or Model: PA0094
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PA0094
Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD

Primary DI Number: 05055331328335
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397134693 *Terms of Use

Device Description: Cytokeratin (AE1/AE3) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human cytokeratins 56.5, 50, 50’, 48 and 40 kD of the acidic subfamily and 65 to 67, 64, 59, 58, 56 and 52 kD of the basic subfamily in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III 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?
57079	Cytokeratin 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 one or multiple cytokeratin subtype(s) 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: 93d7f706-57ff-4567-a491-9319b6a34e5a
Public Version Date: May 25, 2021
Public Version Number: 1
DI Record Publish Date: May 17, 2021