Kappa-APC CYT-KAPPAP-A

GUDID 08436548983505

Kappa-APC

CYTOGNOS SL

Kappa/lambda light chain immunoglobulin IVD, antibody

• Primary Device ID: 08436548983505
• NIH Device Record Key: 121003f4-823c-4ed3-a485-3774e3e0a236
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kappa-APC
• Version Model Number: CYT-KAPPAP-A
• Catalog Number: CYT-KAPPAP-A
• Company DUNS: 563942887
• Company Name: CYTOGNOS SL
• 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: 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

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	08436548983505 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

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: 2022-10-03
• Device Publish Date: 2022-09-23

Devices Manufactured by CYTOGNOS SL

• 08436548983352 - CD38-multi-epitope-FITC: 2022-10-03 CD38-multi-epitope-FITC
• 08436548983369 - CD38-FITC: 2022-10-03 CD38-FITC
• 08436548983376 - CD38-APC-C750™: 2022-10-03 CD38-APC-C750™
• 08436548983390 - CD138-PE: 2022-10-03 CD138-PE
• 08436548983406 - CD19-PE-Cyanine7: 2022-10-03 CD19-PE-Cyanine7
• 08436548983437 - CD3-APC-C750™: 2022-10-03 CD3-APC-C750™
• 08436548983444 - CD45-APC-C750™: 2022-10-03 CD45-APC-C750™
• 08436548983468 - CD45-OC515™: 2022-10-03 CD45-OC515™