FDA.reportPublic FDA data

BOND™

Primary DI
05055331336736
Brand
BOND™
Company
LEICA BIOSYSTEMS NEWCASTLE LTD
Model
PA0989-X
Catalog number
PA0989-X
Device description
MSH2 (Mismatch Repair Protein) (79H11) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human MutS Homolog 2 (MSH2) protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX and BOND-III systems).The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
Published
2022-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055331336736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055331336736050553313367365055331336736

GMDN Terms#

Term, Definition table
TermDefinition
MSH2 antigen IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of MSH2 antigen 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
04065266563085SMAD4 (MRQ-72) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-30
04065266563108SMAD4 (MRQ-72) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-30
04065266563115SMAD4 (MRQ-72) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-30
04065266563139SMAD4 (MRQ-72) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-30
04065266563153SMAD4 (MRQ-72) Rabbit Monoclonal AntibodyCELL MARQUE CORPORATIONNJT2026-09-30
05055331340900BONDLEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-09-25
05055331340917BONDLEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-09-25
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00840542202629Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202636Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
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00840542203138Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203145Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203152Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203169Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203176Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203183Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
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00840542203213Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203268Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22