CD42a-FITC

Basic Information

• Brand Name: CD42a-FITC
• Primary DI: 04049934134296
• Version / Model: 170-081-030
• 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: 84382489-b6e0-4b60-9baa-120570dc951b

Device Description

Clone REA209 recognizes CD42a, a 22 KDa transmembrane glycoprotein, which is also known as glycoprotein IX (GPIX). CD42a is a single-pass type I membrane protein with leucine rich motif containing a series of tandem repeats of a 24-amino acid sequence flanked by conserved disulfide loops, in its ligand binding domains. Expression of CD42a is found on platelets and megakaryocytes. CD42a, together with GPIb receptor complex and platelet glycoprotein V forms a complex which serves as the receptor for von Willebrand factor (VWF). The interaction of the GPIb-IX-V complex to VWF initiates initial platelet adhesion to vascular subendothelium after vascular injury, platelet activation, thrombosis, and hemostasis. Other known ligands for GPIb–IX–V include α-thrombin, clotting factors XI/XIIa, and high-molecular weight kininogen. Additional information: Clone REA209 displays negligible binding to Fc receptors.

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	04049934134296	GS1

Customer Contacts

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

Storage Conditions

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