AccessGUDID - DEVICE: BOND™ (05055331303516)

GUDID

Device Identifier (DI) Information

Brand Name: BOND™
Version or Model: PB0780
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PB0780
Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD

Primary DI Number: 05055331303516
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397134693 *Terms of Use

Device Description: HPV Probe (Subtypes 6,11) is intended to be used for the qualitative identification of the Human Papillomavirus (HPV) DNA in formalinfixed, paraffin-embedded tissue by in situ hybridization (ISH) using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system). This probe binds to the low risk HPV subtypes 6 and 11.

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?
49995	Human papillomavirus (HPV) nucleic acid IVD, probe	A defined piece of single-stranded nucleic acid used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used for diagnosing, monitoring or predicting one or multiple strains of human papillomavirus (HPV) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, Specific, Analyte

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: 1bf05546-1650-48f0-a5ad-e93d78d39486
Public Version Date: March 29, 2021
Public Version Number: 1
DI Record Publish Date: March 19, 2021