CD15-APC

Basic Information

• Brand Name: CD15-APC
• Primary DI: 04049934134104
• Version / Model: 170-081-049
• Company Name: Miltenyi Biotec B.V. & Co. KG
• Labeler DUNS: 342920388
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-26
• Public Version: 1
• Public Version Date: 2021-04-05
• Public Version Status: New
• Public Device Record Key: 398bd632-fe62-475a-a555-7e6e7e4fa29d

Device Description

VIMC6 recognizes the human CD15 antigen which is expressed on human myelomonocytic cells. It is present on neutrophils, eosinophils, and some monocytes, masked on basophils but not on lymphocytes. The antigen is also expressed on Hodgkin/Reed-Sternberg cells. The CD15 antibody recognizes the carbohydrate structure 3-fucosyl-N-acetyl-lactosamine. This structure is also known as stage specific embryonic antigen 1 (SSEA-1) and a common surface marker for pluripotency on mouse ES and iPS cells. On human cells in contrast, SSEA-1 is expressed only on early differentiating cells. The CD15 antibody recognizes the SSEA-1 antigen in both species. For applications in ES and iPS research, the dilution recommended in the data sheet may need adjustment.

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: Yes
• 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
MVU	Reagents, Specific, Analyte	Pathology	864.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64705	Assay development analyte-specific reagent IVD	An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049934134104	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 2 - 8 °C Protected from light.