CAST® Staining Reagent Basophil

FDA UDI

Class I (US FDA UDI)

by Bühlmann Laboratories AG

Identity

Trade Name: CAST® Staining Reagent Basophil FDA UDI
Generic Name: Assay development analyte-specific reagent IVD FDA UDI
Device Name: CAST® Staining Reagent Basophil (B-CCR-SR20) is an analyte-specific reagent (ASR) containing fluorescently labeled anti-CCR3 and anti-CD63 monoclonal antibodies for basophil identification and activation status assessment in basophil activation assays. FDA UDI
Model / Reference: B-CCR-SR20 FDA UDI
Description: CAST® Staining Reagent Basophil (B-CCR-SR20) is an analyte-specific reagent (ASR) containing fluorescently labeled anti-CCR3 and anti-CD63 monoclonal antibodies for basophil identification and activation status assessment in basophil activation assays. FDA UDI

Identifiers

Primary DI / UDI-DI: EBUHBCCRSR20 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Assay development analyte-specific reagent IVD

CAST® Staining Reagent Basophil by Bühlmann Laboratories AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bühlmann Laboratories AG

Sources (1)

FDA UDI 1489116f-89f0-4c39-bd07-27372dad7dbe 33 fields · synced May 30, 2026