FDA.reportPublic FDA data

White blood cell count IVD, kit, cell count

Definition
A collection of reagents and other associated materials intended to be 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 using a manual, semi-automated or automated cell count method.
GUDID devices
26
Last updated
2026-06-18 06:05:24

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00380740137021AlinityABBOTT LABORATORIES07P79042023-11-16
00380740135713CELL-DYNABBOTT LABORATORIES01H77-022016-09-09
00380740135720CELL-DYNABBOTT LABORATORIES01H78-022016-09-09
00805360017992Leucoscreen Test KitVITROLIFE INC.154212018-04-23
08809317540252ADAM-rWBCNanoEnTek, Inc.ADAM-rWBC 2018-06-11
08809317540276ADAM-rWBC SystemNanoEnTek, Inc.ADAM-rWBC System2016-09-30
08809317540498ADAM-rWBC2NanoEnTek, Inc.ADAM-rWBC22018-06-19
08809317540504ADAM-rWBC2 SystemNanoEnTek, Inc.ADAM-rWBC2 System2018-06-19
00382906650061BD FACSuiteBecton, Dickinson And Company6650062022-07-15
08809317540993ADAM-rWBC HTNanoEnTek, Inc.ADAM-rWBC HT2021-02-15
00382903401833N/ABecton, Dickinson And Company3401832020-12-01
00805360016988Leucoscreen Plus Test KitVITROLIFE INC.154472020-04-28
15099590201111Beckman coulterIMMUNOTECHA077992020-01-21
15099590201128BeckmancoulterIMMUNOTECHA078002020-01-21
15099590201135BeckmancoulterIMMUNOTECHA078022020-01-21
15099590201142BeckmancoulterIMMUNOTECHA078032020-01-21
15099590201395BeckmancoulterIMMUNOTECHA097772020-01-21
15099590201500Beckman coulterIMMUNOTECHA118952020-01-21
15099590225940Beckman coulterIMMUNOTECHB311672020-01-21
15099590665555Beckman coulterIMMUNOTECHB311682019-12-18
00630414222899ADVIA 120/2120/2120i® DIFF TIMEpacSiemens Healthcare Diagnostics Inc.103122702016-09-24
00630414601885ADVIA® 560 5P Diff 1LSiemens Healthcare Diagnostics Inc.111708472016-09-24
00380740001131CELL-DYNABBOTT LABORATORIES01H77-022016-09-09
00380740001148CELL-DYNABBOTT LABORATORIES01H78-022016-09-09
00382903409914N/ABecton, Dickinson And Company3409912016-06-08
00382903445639N/ABecton, Dickinson And Company3445632016-06-08