Product code GKZ— Hematology
HemoScreen Hematology Analyzer
- Classification name
- Counter, Differential Cell
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Total cleared
- 381
- First cleared
- Most recent
Clearances under product code GKZ — page 3
201–300 of 381- K950482 — ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)
- K935720 — ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM
- K960427 — ABBOTT CELL-DYN 3500R SYSTEM
- K954570 — ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
- K955909 — MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE
- K953643 — HEMATIL 18 (H-18)
- K953598 — SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS
- K954688 — FLOW-COUNT COULTER FLUOROSPHERES
- K946055 — TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
- K950342 — TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP
- K955504 — QBC ACCUREAD SYSTEM
- K945212 — MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/
- K950916 — CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION
- K950917 — CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
- K950918 — CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION
- K951073 — CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION
- K950919 — CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
- K945756 — IMAGN(TM) 2000 SYSTEM
- K953302 — FACS LOADER SYSTEM
- K933878 — ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT
- K954188 — OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL
- K946335 — OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES
- K940003 — VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT
- K951496 — CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
- K953448 — ROCHE COBAS MICROS HEMATOLOGY ANALYZER
- K953340 — QBC ACCUTUBE
- K945205 — QBC ACCUTUBE
- K945678 — DATACELL 18MS
- K953498 — OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL
- K950742 — CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
- K950057 — TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP
- K952789 — OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES
- K950949 — COULTER MH025A
- K952182 — OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES
- K944126 — CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES
- K944127 — CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY
- K944128 — CALTAG CD4 R-PE MONOCLONAL ANTIBODY
- K945837 — SYSMEX(TM) F-820, 520
- K925255 — TRAX(TM) CD4 TEST KIT
- K950626 — OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES
- K932530 — ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)
- K932531 — ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE
- K932532 — ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE)
- K941713 — ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)
- K943967 — ONYX
- K943894 — SYSMEX K-4500
- K945692 — MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)
- K941171 — TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
- K943284 — MONOCLONAL MOUSE ANTI-HUMAN B-CELL
- K944253 — MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25
- K942797 — MONOCLONAL MOUSE ANTI-HUMAN T-CELL
- K925909 — GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION
- K925274 — AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS
- K933486 — FASCOUNT SYSTME
- K936023 — SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER
- K933475 — TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11
- K933478 — TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11
- K923790 — FACSORT FLOW CYTOMETER
- K930913 — COULTER MH015 (DIFFERENTIAL CELL COUNTER)
- K932030 — COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY
- K924587 — SIMULTEST CD3/ANTI-HLA-DR
- K930309 — ABBOTT ENCOUNTER(TM)Q
- K926124 — CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON
- K930148 — TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)
- K922744 — CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1
- K922745 — CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1
- K923773 — CELLEXIS HEMATOLOGY ANALYZER
- K925528 — BIOVATION K-MANAGER
- K925344 — COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA
- K921279 — CD4 CYTOSPHERES KIT
- K923237 — TECHNICON H*2
- K922181 — COULTER MH009
- K922084 — MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM
- K922085 — MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM
- K922704 — COULTER MAXM W/ AUTOLOADER
- K921567 — COULTER MH017
- K914846 — CD2 MONOCLONAL ANTIBODIES
- K914848 — CD4 MONOCLONAL ANTIBODIES
- K920949 — SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
- K920544 — SYSMEX HEMATOLOGY SYSTEM ACCESSORIES
- K913192 — SIMULTEST(TM) IMK-LYMPHOCYTE
- K915071 — DIFFERENTIAL COUNTING BOARD
- K914744 — SYSMEX NE-1500, MODIFICATION
- K914014 — FACSTRAK FLOW CYTOMETER
- K913305 — CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER
- K901186 — MONOCLONAL ANTIBODY ANTI-CD19
- K901187 — MONOCLONAL ANTIBODY ANTI-CD2
- K901188 — MONOCLONAL ANTIBODY ANTI-CD5
- K901189 — MONOCLONAL ANTIBODY ANTI-CD3
- K910473 — CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC
- K913259 — NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL
- K911626 — SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER
- K911793 — COULTERCLONE
- K911385 — COULTER(R) MH010
- K904253 — ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY
- K910834 — QBC AUTOREADER
- K910283 — DANAM DATACELL-18
- K904390 — ANTI-HUMAN LEU-2A (CD8) PE
- K904209 — SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE
- K903665 — CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY
Data sourced from openFDA. This site is unofficial and independent of the FDA.