BOND PA0990-U

GUDID 05055331336002

MSH6 (Mismatch Repair Protein) (EP49) is a rabbit anti-human monoclonal antibody produced as an affinity-purified tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7ml. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800).

LEICA BIOSYSTEMS NEWCASTLE LTD

MSH6 antigen IVD, antibody

• Primary Device ID: 05055331336002
• NIH Device Record Key: ace7d44c-3b10-447c-8183-ec691a29555f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND
• Version Model Number: PA0990-U
• Catalog Number: PA0990-U
• Company DUNS: 397134693
• Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055331336002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213348

FDA Product Code

• PZJ: Lynch Syndrome Test System

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: 2023-03-13
• Device Publish Date: 2023-03-03

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• 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.
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