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Cd185-Apc

FDA UDI

Class I (US FDA UDI)

by Miltenyi Biotec B.V. & Co. KG

Identity

Trade Name
CD185-APC FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Device Name
REA103 recognizes human CD185, which is a 42 kDa G-protein-coupled chemokine receptor and is also known as CXCR5, monocyte-derived receptor 15 (MDR15), or Burkitt lymphoma receptor-1 (BLR1). BLR-1 was originally identified on cells of Burkitt lymphoma and B cells. B cell attracting chemokine 1 (BCA-1), also known as B-lymphocyte chemoattractant (BLC) or CXCL13, is the ligand of CD185. It is further expressed on central memory CD4 T cells, T follicular helper cells, and on a migratory population of skin-derived dendritic cells. Additional information: Clone REA103 displays negligible binding to Fc receptors. FDA UDI
Model / Reference
170-081-004 FDA UDI
Description
REA103 recognizes human CD185, which is a 42 kDa G-protein-coupled chemokine receptor and is also known as CXCR5, monocyte-derived receptor 15 (MDR15), or Burkitt lymphoma receptor-1 (BLR1). BLR-1 was originally identified on cells of Burkitt lymphoma and B cells. B cell attracting chemokine 1 (BCA-1), also known as B-lymphocyte chemoattractant (BLC) or CXCL13, is the ligand of CD185. It is further expressed on central memory CD4 T cells, T follicular helper cells, and on a migratory population of skin-derived dendritic cells. Additional information: Clone REA103 displays negligible binding to Fc receptors. FDA UDI

Identifiers

Primary DI / UDI-DI
04049934134555 FDA UDI
FDA Product Code
MVU FDA UDI
GMDN Term
Assay development analyte-specific reagent IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Assay development analyte-specific reagent IVD

Cd185-Apc by Miltenyi Biotec B.V. & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assay development analyte-specific reagent IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Miltenyi Biotec B.V. & Co. KG

Sources (1)

  • FDA UDI 5b61dbbc-094a-4817-ba69-f5962289701e 35 fields · synced Jun 8, 2026