← Back to catalogue

CD203c-PE

FDA UDI

Class I (US FDA UDI)

by Miltenyi Biotec B.V. & Co. KG

Identity

Trade Name
CD203c-PE FDA UDI
Generic Name
Assay development analyte-specific reagent IVD FDA UDI
Device Name
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. FDA UDI
Model / Reference
170-081-035 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
04049934134241 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

CD203c-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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Miltenyi Biotec B.V. & Co. KG

Sources (1)

  • FDA UDI 6f971731-857a-4c94-8fc7-c21498e2c719 35 fields · synced May 30, 2026