BOND PA0831-U

GUDID 05055331335456

Anaplastic Lymphoma Kinase (5A4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of ALK and ALK fusion proteins in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems).

LEICA BIOSYSTEMS NEWCASTLE LTD

Anaplastic lymphoma kinase IVD, antibody

• Primary Device ID: 05055331335456
• NIH Device Record Key: 51c66d81-cb19-440f-b97b-e8eeb90c2c4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND
• Version Model Number: PA0831-U
• Catalog Number: PA0831-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
• 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
• 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	05055331335456 [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: 2023-08-07
• Device Publish Date: 2023-07-28

On-Brand Devices [BOND]

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• 05055331303547: Lambda Probe is intended for use in the qualitative identification of Lambda light chain messeng
• 05055331303509: RNA Positive Control Probe is intended for use as a positive control in formalin-fixed, paraffin
• 05055331303493: RNA Negative Control Probe is intended for use in the identification of background staining resu
• 05055331310507: BOND Intense R Detection is a biotin/streptavidin system for the detection of tissue-bound prima
• 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
• 05055331331199: CTLA-4 (CAL49) monoclonal antibody is intended to be used for the qualitative identification by
• 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
• 05055331316561: BOND DAB Enhancer is intended for use as a ready to use solution that intensifies the DAB staini
• 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
• 05055331335494: Immunoglobulin G (RWP49) monoclonal antibody is intended to be used for the qualitative identifi
• 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