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Cd123-Pe

FDA UDI

Class I (US FDA UDI)

by Miltenyi Biotec B.V. & Co. KG

Identity

Trade Name
CD123-PE FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Device Name
AC145 recognizes human CD123, also known as IL-3 receptor alpha-chain. It is the primary low-affinity subunit of the IL-3 receptor. CD123 associates with CD131, the common beta-chain of the IL-3, IL-5, and GM-CSF receptor, to form the high-affinity IL-3 receptor. The IL-3 receptor is involved in cell signaling for cell growth and differentiation. In peripheral blood, the CD123 antigen is expressed at high levels only on plasmacytoid dendritic cells and basophilic granulocytes but at low levels also on monocytes, eosinophilic granulocytes, myeloid dendritic cells, and subsets of hematopoietic progenitor cells. FDA UDI
Model / Reference
170-081-039 FDA UDI
Description
AC145 recognizes human CD123, also known as IL-3 receptor alpha-chain. It is the primary low-affinity subunit of the IL-3 receptor. CD123 associates with CD131, the common beta-chain of the IL-3, IL-5, and GM-CSF receptor, to form the high-affinity IL-3 receptor. The IL-3 receptor is involved in cell signaling for cell growth and differentiation. In peripheral blood, the CD123 antigen is expressed at high levels only on plasmacytoid dendritic cells and basophilic granulocytes but at low levels also on monocytes, eosinophilic granulocytes, myeloid dendritic cells, and subsets of hematopoietic progenitor cells. FDA UDI

Identifiers

Primary DI / UDI-DI
04049934134203 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

Cd123-Pe 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 3d934c43-7df3-4fc9-b87d-9827caee5f05 35 fields · synced May 31, 2026