Ki-67 (SP6) Rabbit Monoclonal Antibody

GUDID 00841683132318

CELL MARQUE CORPORATION

Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody Ki67 antigen IVD, antibody

• Primary Device ID: 00841683132318
• NIH Device Record Key: 1e8a2e60-8509-49cf-8051-e680e7a6ed2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ki-67 (SP6) Rabbit Monoclonal Antibody
• Version Model Number: 275R-16
• Company DUNS: 025048773
• Company Name: CELL MARQUE CORPORATION
• 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: false
• OTC Over-The-Counter: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841683132318 [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: 2020-08-17
• Device Publish Date: 2020-08-07

On-Brand Devices [Ki-67 (SP6) Rabbit Monoclonal Antibody]

• 00841683132318: 275R-16
• 00841683132332: 275R-18
• 00841683132325: 275R-17
• 00841683132301: 275R-15
• 00841683132295: 275R-14
• 00841683107224: 275R-10