FDA.reportPublic FDA data

BOND

Primary DI
05055331337405
Brand
BOND
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
DS9202-U
Catalog number
DS9202-U
Device description
This reagent is a General Purpose Reagent. For Laboratory Use. The BOND-PRIME RNAscope® Brown Detection System enables the user to perform chromogenic in situ hybridization (CISH) on the automated Leica BOND-PRIME system. It is intended for use with nucleic acid probes on formalin-fixed, paraffin-embedded (FFPE) tissue.
Published
2025-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055331337405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055331337405050553313374055055331337405

GMDN Terms#

Term, Definition table
TermDefinition
Propoxyphene IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of propoxyphene in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)2480123tech.support@leicabiosystems.com

Regulatory Flags#

DUNS number
397134693
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055331340900BONDPA0404-UPA0404-U2026-09-25
05055331340917BONDPA0265-UPA0265-U2026-09-25
05055331334725BOND™PA0258-UPA0258-U2022-12-16
05055331315229Novocastra™CBE-356-L-CENCL-L-CBE-3562022-12-07
05055331302038Novocastra™RE7120-CERE7120-K2021-05-17
05055331311788Novocastra™CK20-561-L-CENCL-L-CK20-5612021-04-23
05055331304407BOND™PA0258PA02582021-04-16
05055331321206Novocastra™MSA-L-UNCL-L-MSA2021-04-16
05055331303752BOND™PA0934PA09342021-04-09
05055331303783BOND™PA0906PA09062021-03-12
05055331330581BOND-PRIMECS9300CS93002026-07-08
05055331339607BONDPA0678-UPA0678-U2026-04-10
05055331316967Novocastra™AE1/AE3-L-CENCL-L-AE1/AE32022-12-07
08718858480791Kreatech FISH probes22Q003B4952022-09-21
08718858481231Kreatech FISH probes02P009V5502022-09-21
08718858481248Kreatech FISH probes03Q009V49503Q009V4952022-09-21
08718858481774Kreatech FISH probes02P008V4952022-09-21
08718858481668Kreatech FISH probes03Q001B5502022-08-08
08718858481675Kreatech FISH probes03Q002B4952022-08-08
08718858481712Kreatech FISH probes13Q002C4952022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05407013460206mRNA Buffer 103 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460213mRNA Buffer 103 : 200L BagLonza VerviersPPM2026-09-24
05407013460237mRNA Buffer 112 : 200L BagLonza VerviersPPM2026-09-24
05407013460244mRNA Buffer 112 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460251mRNA Buffer 113 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460268mRNA Buffer 113 : 200L BagLonza VerviersPPM2026-09-24
05407013460282Bulk Packaged ster. filtered WFI - 1LLonza VerviersPPM2026-09-24
04015630967162ISH Peroxidase InhibitorVentana Medical Systems, Inc.PPM2026-07-13
04049016151272FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151289Biotin-labelled anti-human IgGEUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151296FITC-labelled Avidin (biotin affine)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151630FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
00846405014194Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405023417Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
00846405012305Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012312Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012329Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012411Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012428Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012435Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012459Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012466Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012497Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012503Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012510Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012527Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012534Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012541Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012558Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08