BOND PA0756-U

GUDID 05055331336323

This reagent is for in vitro diagnostic use. LEF-1 (EPR2029Y) is intended to be used for the qualitative identification by light microscopy of human LEF-1 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX, BOND-III or BOND-PRIME 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.

LEICA BIOSYSTEMS NEWCASTLE LTD

Lymphoid enhancer factor 1 (LEF1) IVD, antibody Lymphoid enhancer factor 1 (LEF1) IVD, antibody Lymphoid enhancer factor 1 (LEF1) IVD, antibody Lymphoid enhancer factor 1 (LEF1) IVD, antibody Lymphoid enhancer factor 1 (LEF1) IVD, antibody Lymphoid enhancer factor 1 (LEF1) IVD, antibody Lymphoid enhancer factor 1 (LEF1) IVD, antibody Lymphoid enhancer factor 1 (LEF1) IVD, antibody Lymphoid enhancer factor 1 (LEF1) IVD, antibody Lymphoid enhancer factor 1 (LEF1) IVD, antibody Lymphoid enhancer factor 1 (LEF1) IVD, antibody

• Primary Device ID: 05055331336323
• NIH Device Record Key: c3bc0907-b8b7-4792-8ee1-0184da5859f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND
• Version Model Number: PA0756-U
• Catalog Number: PA0756-U
• Company DUNS: 397134693
• Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055331336323 [Primary]

FDA Product Code

• NJT: Immunohistochemistry Reagents And Kits

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-11
• Device Publish Date: 2024-03-01

On-Brand Devices [BOND]

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• 05055331336606: The BOND RNAscope® Protease solution is for enzymatic digestion of formalin-fixed, paraffin-emb
• 05055331331229: PD-1 (CAL20) monoclonal antibody is intended to be used for the qualitative identification by li
• 05055331331205: LAG-3 (12H6) monoclonal antibody is intended to be used for the qualitative identification by li
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• 05055331331182: FOXP3 (236A/E7) monoclonal antibody is intended to be used for the qualitative identification by
• 05055331331175: TIM-3 (EPR22241) monoclonal antibody is intended to be used for the qualitative identification b
• 05055331331151: Muc-4 Glycoprotein (EPR9308) monoclonal antibody is intended to be used for the qualitative iden
• 05055331330994: BOND RNAscope® Brown Detection is intended to enable target visualization by chromogenic in sit
• 05055331329714: S-100 (EP32) monoclonal antibody is intended to be used for the qualitative identification by li
• 05055331328830: MSH2 (Mismatch Repair Protein) (79H11) monoclonal antibody is intended to be used for the qualit
• 05055331328823: PMS2 (Mismatch Repair Protein) (EP51) monoclonal antibody is intended to be used for the qualita
• 05055331328816: MSH6 (Mismatch Repair Protein) (EP49) monoclonal antibody is intended to be used for the qualita
• 05055331327802: The BOND RNAscope® Detection Reagents – BROWN enables the user to perform chromogenic in situ
• 05055331326515: p40 (BC28) monoclonal antibody is intended to be used for the qualitative identification by ligh
• 05055331325303: The BOND FISH Kit enables the user to perform fluorescence in situ hybridization (FISH) on the a
• 05055331317599: BOND Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker a
• 05055331316585: BOND Dewax Solution is a ready to use dewaxing solution intended for removal of paraffin wax fro
• 05055331316578: BOND Primary Antibody Diluent is intended for use as a diluent of individual antibody concentrat
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• 05055331316554: BOND Enzyme Pretreatment Kit consists of an enzyme concentrate and an enzyme diluent, which requ
• 05055331316547: BOND Wash Solution 10X Concentrate is a concentrated buffer solution, requiring initial dilution
• 05055331316530: BOND Epitope Retrieval Solution 2 is a ready to use epitope retrieval solution intended for the
• 05055331316523: BOND Epitope Retrieval Solution 1 is a ready to use epitope retrieval solution intended for the
• 05055331310477: BOND Polymer Define Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker an
• 05055331310460: BOND Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker an
• 05055331305121: BOND Open 30 mL Containers allow the use of reagents from any source on the BOND system.
• 05055331305114: BOND Open 7 mL Containers allow the use of reagents from any source on the BOND system.
• 05055331305107: The BOND Titration Kit contains BOND Titration Container Inserts and BOND Titration Containers.
• 05055331305091: BOND Titration Container Inserts are tubes that fit directly into the BOND Titration Containers.
• 05055331336019: PMS2 (Mismatch Repair Protein) (EP51) is a rabbit anti-human monoclonal antibody produced as an
• 05055331336002: MSH6 (Mismatch Repair Protein) (EP49) is a rabbit anti-human monoclonal antibody produced as an
• 05055331335920: MSH2 (Mismatch Repair Protein) (79H11) is a mouse anti-human monoclonal antibody produced as a t
• 05055331335906: MLH1 (Mismatch Repair Protein) (ES05) is a mouse anti-human monoclonal antibody produced as a ti
• 05055331332820: BOND ChromoPlex II Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP) and p
• 05055331335531: Smooth Muscle Actin (alpha sm-1) monoclonal antibody is intended to be used for the qualitative
• 05055331335524: Cytokeratin 7 (RN7) monoclonal antibody is intended to be used for the qualitative identificatio
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• 05055331335487: Carcinoembryonic Antigen (CD66e) (COL-1) monoclonal antibody is intended to be used for the qual
• 05055331335470: CD19 (BT51E) monoclonal antibody is intended to be used for the qualitative identification by li
• 05055331335463: Programmed Death Ligand 1 (73-10) monoclonal antibody is intended to be used for the qualitative
• 05055331335456: Anaplastic Lymphoma Kinase (5A4) monoclonal antibody is intended to be used for the qualitative
• 05055331335432: CD30 (JCM182) monoclonal antibody is intended to be used for the qualitative identification by l