AccessGUDID - DEVICE: BOND™ (05055331335104)

GUDID

Device Identifier (DI) Information

Brand Name: BOND™
Version or Model: PA0436-U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PA0436-U
Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD

Primary DI Number: 05055331335104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397134693 *Terms of Use

Device Description: BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) is a monoclonal antibody intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX or BOND-III systems. Progesterone Receptor Clone (16) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.

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?
57210	Estrogen (oestrogen)/progesterone receptor 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 estrogen (oestrogen) and/or progesterone receptors in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MXZ	Immunohistochemistry Assay, Antibody, Progesterone Receptor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193393	000

Device Exempt from Premarket Submission: No 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: 74422863-92e1-4459-b90b-143deb196216
Public Version Date: December 26, 2022
Public Version Number: 1
DI Record Publish Date: December 16, 2022