CA19-9 (121SLE) Mouse Monoclonal Antibody

Basic Information

• Brand Name: CA19-9 (121SLE) Mouse Monoclonal Antibody
• Primary DI: 00841683100058
• Version / Model: 760-2609
• Company Name: CELL MARQUE CORPORATION
• Labeler DUNS: 025048773
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-15
• Public Version: 1
• Public Version Date: 2021-04-23
• Public Version Status: New
• Public Device Record Key: f2e8c766-8988-49db-9f4c-383632c6b3d7

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56889	Cancer antigen 19-9 (CA19-9) GI IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of gastrointestinal and pancreatic cancer antigen 19-9 (CA19-9) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841683100058	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius