FDA.reportPublic FDA data

Full blood count IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].
GUDID devices
311
Last updated
2026-06-05 06:05:26

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816068020238Advanced Instruments GloCyte® Controls KitAdvanced Instruments, LLC1110132016-09-23
00630414290058Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.113743132026-02-06
00630414290065Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.113743142026-02-06
00630414290072Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.113743152026-02-06
00630414290119Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.113743192026-02-06
00630414290126Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.113743202026-02-06
10815762020091Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.3D5012016-12-20
10815762020190Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.3D5152016-12-20
10815762020251Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.3K3012016-07-29
10815762020343Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.720012016-07-29
10815762020435Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.HC7252016-07-29
10815762020442Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.HC7272016-07-29
10815762020763Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.ST0012016-07-29
10815762020862Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.CT0012016-07-29
10815762021081Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.HGB7252016-07-29
10815762021098Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.HGB7272016-07-29
00630414323534Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.113743152026-02-06
00630414323572Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.113743192026-02-06
00630414323589Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.113743202026-02-06
00630414323640Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.113743132026-02-06
00630414323657Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.113743142026-02-06
00815762020490Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.PIX0022025-12-01
00850063751315CitoCBC ControlCYTOCHIP INC13102025-07-01
00815762026362Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.XN0042025-06-06
00815762026508Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.CL0372025-06-04
03610230008584BFTROLHORIBA ABX SAS13000394052024-09-26
03610230009581ABX Minotrol 16HORIBA ABX SAS53001003122024-09-25
03610230009598ABX Minotrol 16HORIBA ABX SAS53001003062024-09-25
03610230009604ABX Minotrol 16HORIBA ABX SAS53001003032024-09-25
00815762020520R&D CBC-XR Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.XR0102024-04-02
00815762020537R&D CBC-XR Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.XR0042024-04-02
00815762020605R&D CBC-XR Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.XR0022024-04-02
00380740151270AlinityAbbott GmbH04U72062023-11-16
00380740151287AlinityAbbott GmbH04U72122023-11-16
06944904031408BC-6D Hematology ControlShenzhen Mindray Bio-Medical Electronics Co., Ltd.BC-6D2023-10-19
06944904031422BC-RET Hematology ControlShenzhen Mindray Bio-Medical Electronics Co., Ltd.BC-RET2023-10-19
00815762026331R&D CBC-DH Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.DH0022023-06-30
00815762026348R&D CBC-DH Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.DH0042023-06-30
14987562507990Platelet CHECKSYSMEX CORPORATIONCN4649982021-11-30
14987562508003Platelet CHECKSYSMEX CORPORATIONCC1183602021-11-30
14987562502742XN CHECKSYSMEX CORPORATIONNSL-100G2021-01-18
14987562502759XN CHECKSYSMEX CORPORATIONNSN-100G2021-01-18
14987562502766XN CHECKSYSMEX CORPORATIONNSH-100G2021-01-18
30844509000199Para 12® PlusSTRECK, INC.2305922020-08-24
B787OCK10OLO Control KitS.D. SIGHT DIAGNOSTICS LTDOCK12020-05-04
15099590671884DxH 500 Series ControlBECKMAN COULTER IRELAND INC.B368722019-05-01
15099590704827Coulter 6C Plus Cell ControlBeckman Coulter, Inc.C072972019-04-11
14987562460257RANGE CHECK X llSYSMEX CORPORATION130-4003-02016-08-05
14987562460264EIGHTCHECK-3WPSYSMEX CORPORATION140-3004-02016-08-05
14987562460288e-CHECKSYSMEX CORPORATION199-4004-12016-08-05
14987562460295e-CHECK(XE)SYSMEX CORPORATION201-6001-02016-08-05
14987562460301XN CHECKSYSMEX CORPORATION2134992016-08-05
14987562460318XN CHECK BFSYSMEX CORPORATION2135162016-08-05
14987562460387RANGE CHECK X lllSYSMEX CORPORATION2189812016-08-05
14987562460394XN-L CHECKSYSMEX CORPORATIONAS7477502017-02-20
14987562460561e-CHECK(XS)SYSMEX CORPORATION199-5001-02017-10-06
14987562460578e-CHECK(XS)SYSMEX CORPORATION199-5002-02016-08-05
14987562460608plt-CHECKSYSMEX CORPORATION200-4004-02017-10-06
14987562460615plt-CHECKSYSMEX CORPORATION200-4004-12017-10-06
14987562461780WRP CHECKSYSMEX CORPORATIONBG2347842017-02-14
14987562461797WRP CHECK EXSYSMEX CORPORATIONAX8446192017-02-14
14987562490216XW QC CHECKSYSMEX CORPORATIONBP9357642018-02-13
15099590205553COULTER 6CBeckman Coulter, Inc.A599252016-09-23
15099590206802COULTER LIN-X Beckman Coulter, Inc.A811962016-09-23
15099590222277COULTER 4C-ESBeckman Coulter, Inc.75472022016-09-23
15099590222284COULTER 5CBeckman Coulter, Inc.75471992016-09-23
15099590222291COULTER 4C-ESBeckman Coulter, Inc.75471902016-09-23
15099590222307COULTER 4C-ESBeckman Coulter, Inc.75471892016-09-23
15099590222314COULTER 4C-ESBeckman Coulter, Inc.75471882016-09-23
15099590224288COULTER LIN-C Beckman Coulter, Inc.7235032016-09-23
15099590225209COULTER 5CBeckman Coulter, Inc.75471162016-09-23
15099590225216COULTER 4C PlusBeckman Coulter, Inc.75471142016-09-23
15099590225223COULTER LIN-C Beckman Coulter, Inc.75470652016-09-23
15099590230302COULTER 4C PlusBeckman Coulter, Inc.75470252016-09-23
15099590230319COULTER 5CBeckman Coulter, Inc.75470112016-09-23
15099590230326COULTER 5CBeckman Coulter, Inc.75470102016-09-23
15099590230333COULTER 4C-ESBeckman Coulter, Inc.75471872016-09-23
15099590230371COULTER 5CBeckman Coulter, Inc.75470012016-09-23
15099590230401COULTER 5CBeckman Coulter, Inc.75471242016-09-23
15099590230418COULTER 5CBeckman Coulter, Inc.75471172016-09-23