CD94-APC

Basic Information

• Brand Name: CD94-APC
• Primary DI: 04049934134265
• Version / Model: 170-081-033
• 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: 883285aa-4234-4b7f-ad06-a178c07fe593

Device Description

REA113 recognizes CD94, an approximately 45 kDa, single pass, type II transmembrane protein, which belongs to C-type lectin superfamily. CD94 associates covalently with NKG2 family members and forms disulfide-bonded heterodimers. CD94-NKG2 receptors bind HLA-E, the non-classical MHC class Ib molecule. Depending on the associated NKG2 member, CD94-NKG2 heterodimer transmits either activating or inhibitory signal. For example, via immunoreceptor tyrosine–based inhibitory motifs (ITIMs) containing NKG2A, CD94-NKG2A heterodimers inhibit NK cell cytotoxicity. Besides NK cells, expression of CD94-NKG2 heterodimers is also shown on NK-T cells and a small percentage of CD8 cells in mice, where the crosslinking of CD94-NKG2 was shown to reduce the level of spontaneous apoptosis. Additional Information: Clone REA113 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	04049934134265	GS1

Customer Contacts

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

Storage Conditions

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