FDA.reportPublic FDA data

CAST® Lysing Reagent Basophil

Primary DI
EBUHBCCRLYR20
Brand
CAST® Lysing Reagent Basophil
Company
Bühlmann Laboratories AG
Model
B-CCR-LYR20
Device 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
Published
2025-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
GGKProducts, Red-Cell Lysing Products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGKProducts, Red-Cell Lysing ProductsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBUHBCCRLYR20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood cell lysis reagent IVDA substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481261006
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EBUHBKPELARSET0BÜHLMANN fPELA® turbo Reagent KitB-KPELA-RSET2020-06-22
EBUHKKACK20BÜHLMANN ACE KineticKK-ACK2KK-ACK22025-06-27
EBUHKKACK21ACE Kinetic KitKK-ACK2KK-ACK22016-09-01
EBUHBCCRSR20CAST® Staining Reagent BasophilB-CCR-SR202025-03-04
EBUHBCCRSTB5CAST® Stimulation Buffer BasophilB-CCR-STB52025-03-04
EBUHBCCRSTCON10CAST® Stimulation Control BasophilB-CCR-STCON102025-03-04
EBUHBCCRWB10CAST® Wash Buffer BasophilB-CCR-WB102025-03-04
EBUHBKCALRSETUS0BÜHLMANN fCAL® turbo Reagent KitB-KCAL-RSET-US2023-05-02
04260714340007fCAL turbo089103671902022-06-13
EBUHBCALSAMPLER250Simple Sampler Stool Collection SetB-CAL-SAMPLER252023-06-26
EBUHBKPELACONSET0BÜHLMANN fPELA® turbo Control KitB-KPELA-CONSET2020-06-22
EBUHKPELACASET0BÜHLMANN fPELA® turbo Calibrator KitB-KPELA-CASET2020-06-22
07613336169926fCAL turbo089103321902020-05-27
EBUH089104991900fCAL Calibrator Set089104991902020-05-27
EBUHBEKCAL0BÜHLMANN fCAL® ELISAEK-CAL2019-11-06
EBUHBEKCAL20BÜHLMANN fCAL® ELISAEK-CAL22019-11-06
EBUHBKCALCASET0BÜHLMANN fCAL® turbo Calibrator KitB-KCAL-CASET2019-11-01
EBUHBKCALRSET0BÜHLMANN fCAL® turbo Reagent KitB-KCAL-RSET2019-11-01
EBUHBIPOCTRABS0Quantum Blue® ReaderBI-POCTR-ABS2021-01-12
EBUH089109870010CALEX Cap089109870012020-05-27

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