Genemed® 60-0037-7

GUDID 00615233006608

anti-Human Kappa Light Chain Mouse Monoclonal Antibody [HP6053], Ready-To-Use, 7 mL

SAKURA FINETEK U.S.A., INC.

Kappa/lambda light chain immunoglobulin IVD, antibody

• Primary Device ID: 00615233006608
• NIH Device Record Key: 56d10dfb-e787-4c64-931f-293baaf5d14c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genemed®
• Version Model Number: 60-0037-7
• Catalog Number: 60-0037-7
• Company DUNS: 179135769
• Company Name: SAKURA FINETEK U.S.A., INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(310)972-7800
• Email: TS@sakuraus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615233006608 [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: 2020-01-06
• Device Publish Date: 2019-12-28

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