FDA.reportPublic FDA data

White blood cell count IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen.
GUDID devices
23
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10664369201385STROMATOLYSER-4DSSYSMEX CORPORATIONFFS-800A2022-11-04
06009544049579N/ASOUTHERN IMPLANTS (PTY) LTDMSC-SP45102024-11-27
08809317540269ADAM-rWBC KitNanoEnTek, Inc.AD1K-0502016-09-30
80664369201384STROMATOLYSER-4DSSYSMEX CORPORATIONFFS-800A2022-11-04
08809317541006ADAM-rWBC KitNanoEnTek, Inc.ADHK-0502021-02-15
00192024092304Ricca Chemical Company®Ricca Chemical Company, LLC8850-322021-02-04
00192024092311Ricca Chemical Company®Ricca Chemical Company, LLC8850-12021-02-04
00192024092328Ricca Chemical Company®Ricca Chemical Company, LLC8850-162021-02-04
15099590539931Whole Blood Lysing Reagent KitBeckman Coulter, Inc.66027642020-08-31
15099590225803AQUIOSBECKMAN COULTER IRELAND INC.B235382016-09-23
15099590537258IMMUNOPREP REAGENT WHOLE BLOOD LYSINGBeckman Coulter, Inc.75469992016-09-23
15099590537265Q-PREP/IMMUNOPREP REAGENT SYSTEMBeckman Coulter, Inc.75469462016-09-23
15099590538088LeukoSure Enumeration KitBeckman Coulter, Inc.1756212016-09-23
15099590543389Whole Blood Lysing Reagent Beckman Coulter, Inc.300 tests2019-02-15
04061609000057Leuko-TIC VTBIOANALYTIC GmbH, biomed. Analysentechnik004005-60102018-02-06
04061609000064Leuko-TIC VT plusBIOANALYTIC GmbH, biomed. Analysentechnik004005-61002018-02-06
04061609000071Leuko-TIC SF 1:100BIOANALYTIC GmbH, biomed. Analysentechnik004008-60102018-02-06
04061609000088Leuko-TIC SF 1:100 plusBIOANALYTIC GmbH, biomed. Analysentechnik004008-61002018-02-06
04061609000149Leuko-TIC 1:20 blauBIOANALYTIC GmbH, biomed. Analysentechnik004013-00062018-02-06
04061609000156Leuko-TIC 1:20 blau plusBIOANALYTIC GmbH, biomed. Analysentechnik004013-00072018-02-06
04061609000163LeukoCount blauBIOANALYTIC GmbH, biomed. Analysentechnik004013-01002018-02-06
04061609000170LeukoCount blauBIOANALYTIC GmbH, biomed. Analysentechnik004013-05002018-02-06
04061609000187Leuko-TIC 1:20 blauBIOANALYTIC GmbH, biomed. Analysentechnik004013-60102018-02-06