CAST® Lysing Reagent Basophil

FDA UDI

Class I (US FDA UDI)

by Bühlmann Laboratories AG

Identity

Trade Name: CAST® Lysing Reagent Basophil FDA UDI
Generic Name: Blood cell lysis reagent IVD FDA UDI
Device Name: CAST® Lysing Reagent Basophil (B-CCR-LYR20) is a red cell lysing reagent designed for selective lysis of erythrocytes in basophil activation assays, ensuring optimal basophil analysis by flow cytometry FDA UDI
Model / Reference: B-CCR-LYR20 FDA UDI
Description: CAST® Lysing Reagent Basophil (B-CCR-LYR20) is a red cell lysing reagent designed for selective lysis of erythrocytes in basophil activation assays, ensuring optimal basophil analysis by flow cytometry FDA UDI

Identifiers

Primary DI / UDI-DI: EBUHBCCRLYR20 FDA UDI
FDA Product Code: GGK FDA UDI
GMDN Term: Blood cell lysis reagent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.8540 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

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Blood cell lysis reagent IVD

CAST® Lysing 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 8a3264a9-1f39-4fe2-acf0-891b5a2ed1cf 33 fields · synced May 30, 2026