FDA.report

BOND™

Primary DI
05055331303486
Brand
BOND™
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
PB0829
Catalog number
PB0829
Device description
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.
Published
2021-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MVUReagents, Specific, Analyte

Product Code Classifications

CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055331303486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055331303486050553313034865055331303486

GMDN Terms

TermDefinition
Human papillomavirus (HPV) nucleic acid IVD, probeA 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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)2480123tech.support@leicabiosystems.com

Regulatory Flags

DUNS number
397134693
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05055331336323BONDPA0756-UPA0756-U2024-03-01
05055331336330BONDPA0713-UPA0713-U2024-03-01
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05055331336361BONDPA0310-UPA0310-U2024-03-01
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05055331300171NovocastraVWF-L-UNCL-L-VWF-U2023-07-28
05055331320704NovocastraCD163-L-UNCL-L-CD163-U2023-07-28
05055331320803NovocastraCK17-L-UNCL-L-CK17-U2023-07-28
05055331321107NovocastraP57-L-UNCL-L-P57-U2023-07-28
05055331321138NovocastraCD16-L-UNCL-L-CD16-U2023-07-28
05055331321374NovocastraCD13-304-L-UNCL-L-CD13-304-U2023-07-28

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