CD203c-PE

Basic Information

• Brand Name: CD203c-PE
• Primary DI: 04049934134241
• Version / Model: 170-081-035
• 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: 6f971731-857a-4c94-8fc7-c21498e2c719

Device Description

Clone FR3-16A11 recognizes CD203c, a glycosylated type II transmembrane molecule that belongs to the family of ecto-nucleotide pyrophosphatase/ phosphodiesterase (E-NPP3) enzymes. Among hematopoietic cells, expression of CD203c is restricted to basophils as well as to mast cells and their precursors, and has been described as specific for this lineage. Protein and/or mRNA expression of CD203c has also been found in solid tissues such as uterus or prostate. Basophils and mast cells are key producers of mediators that drive the onset of inflammatory responses, e.g., in allergy. Allergen challenge leads to a rapid up-regulation of activation markers such as CD203c or CD63. Due to its restricted expression pattern, CD203c is discussed as a specific marker to monitor the allergen-induced activation of basophils, e.g., in flow cytometric basophil activation tests of the peripheral blood.

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	04049934134241	GS1

Customer Contacts

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

Storage Conditions

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