DEVICE: BOND™ (05055331303486)
Device Identifier (DI) Information
BOND™
PB0829
In Commercial Distribution
PB0829
LEICA BIOSYSTEMS NEWCASTLE LTD
PB0829
In Commercial Distribution
PB0829
LEICA BIOSYSTEMS NEWCASTLE LTD
HPV Probe (Subtypes 16, 18, 31, 33, 51) is intended to be used for the qualitative identification of the Human Papillomavirus (HPV) DNA
in formalin-fixed, 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 five high risk HPV subtypes, 16, 18, 31, 33 and 51.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
07e48681-8651-4e29-8163-17df852cdeaa
March 29, 2021
1
March 19, 2021
March 29, 2021
1
March 19, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)2480123
tech.support@leicabiosystems.com
tech.support@leicabiosystems.com