| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 08809317541006 | ADAM-rWBC Kit | ADHK-050 | It is used for the quantitative determination of the residual white blood cell ( It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC HT. | GKZ | Counter, Differential Cell | 2 | ADAM |
| 2 | 08809317540993 | ADAM-rWBC HT | The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual white blood cells (rWBCs) in leukoreduced blood products. | GKZ | Counter, Differential Cell | 2 | ADAM | |
| 3 | 08809317540252 | ADAM-rWBC | ADAM-rWBC device | ADAM-rWBC is a device to count white blood cell. It is used with ADAM-rWBC kit. | GKZ | Counter, Differential Cell | 2 | ADAM |
| 4 | 08809317540634 | ADAMII-CD34 Kit | CD34K-050 | ADAMII-CD34 Kit is designed for use with the ADAMII instrument, benchtop image-b ADAMII-CD34 Kit is designed for use with the ADAMII instrument, benchtop image-based fluorescence cell counter.ADAMII-CD34 Kit provides the percentages of total and viable cells that are CD34+(%CD34). | GKZ | Counter, Differential Cell | 2 | ADAM |
| 5 | 08809317540627 | ADAMII | ADAM2 | ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, e ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients. | GKZ | Counter, Differential Cell | 2 | ADAM |
| 6 | 08809317540504 | ADAM-rWBC2 | ADAM-rWBC2 | ADAM-rWBC2 System is composted ADAM-rWBC2(equipment) and ADAM-rWBC Kit (reagent) ADAM-rWBC2 System is composted ADAM-rWBC2(equipment) and ADAM-rWBC Kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in the human specimen. | GKZ | Counter, Differential Cell | 2 | ADAM |
| 7 | 08809317540498 | ADAM-rWBC2 | ADAM-rWBC2 device | ADAM-rWBC2 is a device to count white blood cell. It is used with ADAM-rWBC Kit. | GKZ | Counter, Differential Cell | 2 | ADAM |
| 8 | 08809317540276 | ADAM-rWBC | ADAM-rWBC | ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in human specimen. | GKZ | Counter, Differential Cell | 2 | ADAM |
| 9 | 08809317540924 | FREND COVID-19 total Ab | FRCOA 020 | The COVID-19 total Ab is designed for the qualitative and quantitative measureme The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA,and citrate) by fluorescence immunoassay (FIA) using the FREND™ System. | QKO | Reagent, Coronavirus Serological | FREND | |
| 10 | 08809317540917 | COVID-19 total Ab Control LQ | FIC-COALQ | The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COV The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard. | QKO | Reagent, Coronavirus Serological | FREND | |
| 11 | 08809317540825 | FREND Blocking Reagent | FRBR 015 | FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state. | PPM | General Purpose Reagent | 1 | FREND |
| 12 | 08809317540566 | FREND Vitamin D Linearity Kit | FLK-VTD | FREND™ TSH Linearity Kit is intended for use as an assayed linearity material fo FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | FREND |
| 13 | 08809317540207 | FREND System | F10 | FREND System is designed for reding the FREND cartridge of a quantitative. | KHO | Fluorometer, For Clinical Use | 1 | FREND |
| 14 | 08809317540559 | FREND TSH Linearity Kit | FLK-TSH | FREND™ TSH Linearity Kit is intended for use as an assayed linearity material fo FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | FREND |
| 15 | 08809317540542 | FREND Testosterone Linearity Kit | FLK-TES | FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity ma FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity material for the testosterone on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ Testosterone Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | FREND |
| 16 | 08809317540535 | FREND PSA Plus Linearity Kit | FLK-PSA | FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity materi FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity material for the prostate-specific antigen (PSA) on the FREND™ System. The Linearity kit is for the FREND™ System only.FREND™ PSA Plus Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | FREND |
| 17 | 08809317540528 | FREND Free T4 Linearity Kit | FLK-FT4 | FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity materia FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity material for the free thyroxine (Free T4) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ Free T4 Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | FREND |
| 18 | 08809317540481 | FREND PSA Plus | FRPS 025 | It is used for the quantitiative determination of Prostate Specific Antigen(PSA) It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System. | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 2 | FREND |
| 19 | 08809317540467 | FREND AP | F10AP | JRG | Block, Heating | 1 | FREND | |
| 20 | 08809317540382 | FRT4-AP | FRT4AP 020 | It is used for the quantitative determination of free thyroxine(free t4) in huma It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System. | CEC | Radioimmunoassay, Free Thyroxine | 2 | FREND |
| 21 | 08809317540375 | FRTE-AP | FRTEAP 020 | It is used for the quantitative measurement of Total Testosterone in human serum It is used for the quantitative measurement of Total Testosterone in human serum or heparinized, EDTA plasma sample. | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | FREND |
| 22 | 08809317540337 | FRVD-AP | FRVDAP 020 | It is used for the quantitative measurement of 25-hydroxy vitamin D and related It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plasma. | MRG | System, Test, Vitamin D | 2 | FREND |
| 23 | 08809317540191 | FREND Free T4 | FRT4 020 | It is used for the quantitative determination of free thyroxine(free t4) in huma It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System. | CEC | Radioimmunoassay, Free Thyroxine | 2 | FREND |
| 24 | 08809317540184 | FREND PSA Plus | FRPS 025 | It is used for the quantitiative determination of Prostate Specific Antigen(PSA) It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System. | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | 2 | FREND |
| 25 | 08809317541143 | ADRC 020 | ADRC 020 | The r-Control RBC and PLT consists of red blood cell (RBC) Low & RBC High proces The r-Control RBC and PLT consists of red blood cell (RBC) Low & RBC High process controls and platelet (PLT) Low & PLT High process controls. It is intended for use with ADAM-rWBC Kit to monitor the process for enumeration of residual leukocytes in leukocyte reduced RBC and PLT products, including dilution, staining, instrument setup, and white blood cell (WBC) enumeration. For in vitro diagnostic use only. | MZG | Test, Residual, Wbc In Leukoreduced Blood | 2 | r-Control RBC and PLT |
| 26 | 08809317540719 | DHC-F0420 | DHC-F0420 | The DHC-F0420 grid pattern is exactly the same as the Fuchs-Rosenthal. It consis The DHC-F0420 grid pattern is exactly the same as the Fuchs-Rosenthal. It consists of 16 large squares orientated by triple lines, each measuring 1 x 1 mm, giving a total area 4 x 4 mm. | GHO | Hemocytometer | 1 | C-Chip |
| 27 | 08809317540702 | DHC-F04 | DHC-F04 | The DHC-F04 grid pattern is exactly the same as the Fuchs-Rosenthal. It consists The DHC-F04 grid pattern is exactly the same as the Fuchs-Rosenthal. It consists of 16 large squares orientated by triple lines, each measuring 1 x 1 mm, giving a total area 4 x 4 mm. | GHO | Hemocytometer | 1 | C-Chip |
| 28 | 08809317540696 | DHC-B0420 | DHC-B0420 | The DHC-B0420 grid pattern is exactly same as the Burker. It consists of 9 large The DHC-B0420 grid pattern is exactly same as the Burker. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3. | GHO | Hemocytometer | 1 | C-Chip |
| 29 | 08809317540689 | DHC-B04 | DHC-B04 | The DHC-B04 grid pattern is exactly same as the Burker. It consists of 9 large s The DHC-B04 grid pattern is exactly same as the Burker. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3. | GHO | Hemocytometer | 1 | C-Chip |
| 30 | 08809317540672 | DHC-N0420 | DHC-N0420 | The DHC-N0420 grid pattern is exactly same as the Neubauer Improved. It consists The DHC-N0420 grid pattern is exactly same as the Neubauer Improved. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3. | GHO | Hemocytometer | 1 | C-Chip |
| 31 | 08809317540665 | DHC-N04 | DHC-N04 | The DHC-N04 grid pattern is exactly same as the Neubauer Improved. It consists o The DHC-N04 grid pattern is exactly same as the Neubauer Improved. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3. | GHO | Hemocytometer | 1 | C-Chip |
| 32 | 08809317540603 | DHC-M01 | DHC-M01 | The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leu The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-M01 grid pattern is exactly same as the Malassez. It consists of 25 large squares, each measuring 0.2 x 0.25 mm and the depth of the chamber is 0.2 mm. Each square has a total volume of 0.01 mm3 or 10-5 cm3.The large squares are subdivided into 20 small squares with an area of 0.0025 mm2.Cells per mL = average count per large square x dilution factor x 105 (dilution factor) | GHO | Hemocytometer | 1 | C-Chip |
| 33 | 08809317540597 | DHC-F01 | DHC-F01 | The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leu The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-F01 grid pattern is exactly the same as the Fuchs-Rosenthal. It consists of 16 large squares orientated by triple lines, each measuring 1 x 1 mm, giving a total area 4 x 4 mm. | GHO | Hemocytometer | 1 | C-Chip |
| 34 | 08809317540580 | DHC-B02 | DHC-B02 | The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leu The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-B02 grid pattern is exactly the same as the Burker-Turk. It consists of 9 large squares, each measuring 1 x 1 mm and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3.The large squares are subdivided into 16 group squares with 0.2 mm sides. In the central large square, each group is subdivided into 16 mini squares with 0.05 mm sides (=0.0025 mm2). | GHO | Hemocytometer | 1 | C-Chip |
| 35 | 08809317540573 | DHC-B01 | DHC-B01 | The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leu The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-B01 grid pattern is exactly the same as the Burker. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3.The large squares are subdivided into 16 group squares with 0.2 mm sides. The group squares correspond in size to the Neubauer grid but have no further subdivisions. | GHO | Hemocytometer | 1 | C-Chip |
| 36 | 08809317540511 | DHC-N01 | DHC-N01 | The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leu The C-Chip is a disposable plastic chamber used for blood cell (Erythrocyte, Leukocyte) counting. It consists of surface-patterned two enclosed chambers with two ports for sample injection. The DHC-N01 grid pattern is exactly same as the Neubauer Improved. It consists of 9 large squares, each measuring 1 x 1 mm, and the depth of the chamber is 0.1 mm. Each square has a total volume of 0.1 mm3 or 10-4 cm3 (Fig. 1). The central square is divided into 25 small squares with triple lines and four corner squares are divided into 16 small squares. | GHO | Hemocytometer | 1 | C-Chip |
| 37 | 08809317540153 | FREND Testosterone | FRTE 020 | It is used for the quantitiative determination of Testosterone in human specimen It is used for the quantitiative determination of Testosterone in human specimen using FREND System. | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | FREND |
| 38 | 08809317540016 | FREND TSH | FRTS 025 | It is used for the quantitative determination of Thyroid Stimulating Hormone in It is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System. | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | FREND |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 07611969952885 | 823102 | 823102 | for 6 detections of human HLA-DR/DQ antigens in the complement-dependent microly for 6 detections of human HLA-DR/DQ antigens in the complement-dependent microlymphocytotoxicity test | Lymphotype HLA-DR/DQ 72 | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| 2 | 07350040974322 | XU-10288-01 | XU-10288-01 | Automated cell locating device. DM9600 automatically locates and presents images Automated cell locating device. DM9600 automatically locates and presents images of blood cells on peripherall blood smears. | CellaVision® DM9600 | CELLAVISION AB |
| 3 | 07350040972564 | CBF-960099 | CBF-960099 | The body fluid application automatically locates and presents cell images on cyt The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations. | CellaVision® Body Fluid Application DM96 | CELLAVISION AB |
| 4 | 07350040972021 | CC286297 | CC286297 | Automated Digital Morphology Analyzer DI-60 automaticall locates and presents im Automated Digital Morphology Analyzer DI-60 automaticall locates and presents images of blood cells on peripheral blood smears | Automated Digital Morphology Analyzer DI-60 | CELLAVISION AB |
| 5 | 07350040971277 | XU-10127-01 | XU-10127-01 | Automated cell locating device. DM1200 automatically locates and presents images Automated cell locating device. DM1200 automatically locates and presents images of blood cells on peripherall blood smears. | CellaVision® DM1200 | CELLAVISION AB |
| 6 | 07350040970201 | XU-10020-01 | XU-10020-01 | Automated cell locating device. DM96 automatically locates and presents images o Automated cell locating device. DM96 automatically locates and presents images of blood cells on peripherall blood smears. | CellaVision® DM96 | CELLAVISION AB |
| 7 | 07350040796375 | M16S BD ABR US | 1400075 | A fully automatic, 3-part differential, hematology analyzer intended for in vitr A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic testing of blood specimens under laboratory conditions. | Medonic M-series | BOULE MEDICAL AB |
| 8 | 07350040796368 | M16C US | 1400074 | A fully automatic, 3-part differential, hematology analyzer intended for in vitr A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic testing of blood specimens under laboratory conditions | Medonic M-series | BOULE MEDICAL AB |
| 9 | 07350040796351 | M16M US | 14000073 | A fully automatic, 3-part differential, hematology analyzer intended for in vitr A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic testing of blood specimens under laboratory conditions | Medonic M-series | BOULE MEDICAL AB |
| 10 | 07350040796344 | M16 US | 1400106 | A fully automatic, 3-part differential, hematology analyzer intended for in vitr A fully automatic, 3-part differential, hematology analyzer intended for in vitro diagnostic testing of blood specimens under laboratory conditions | Medonic M-series | BOULE MEDICAL AB |
| 11 | 07290016991079 | CBC Sampler | BC-MA-00100 | A disposable unit used for the collection of the blood sample | HemoScreen | PIXCELL MEDICAL TECHNOLOGIES LTD |
| 12 | 07290016991048 | CBC Sampler | BC-FA-00201 | A disposable unit used for the collection of the blood sample | HemoScreen | PIXCELL MEDICAL TECHNOLOGIES LTD |
| 13 | 07290016991017 | CBC Cartridge | BC-FA-00103 | A self-contained disposable unit in which a single blood sample is prepared and A self-contained disposable unit in which a single blood sample is prepared and made ready for measurement and CBC analysis | HemoScreen | PIXCELL MEDICAL TECHNOLOGIES LTD |
| 14 | 07290016991000 | HemoScreen 200 | The HemoScreen is a quantitative automated hematology analyzer intended for in v The HemoScreen is a quantitative automated hematology analyzer intended for in vitro diagnostic point-of-care (POC) use to classify and enumerate the following parameters for capillary and venous whole blood (K2 EDTA anticoagulated) in adults and children at least 2 years of age: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV NEUT%, NEUT#, LYMPH%, LYMP#, MONO%, MONO#, EO%, EO#, BASO%, and BASO#. The HemoScreen analyzer is indicated for use in clinical laboratories, and in POC settings | HemoScreen | PIXCELL MEDICAL TECHNOLOGIES LTD | |
| 15 | 07290012140792 | VS-MA-00892-00 | VS-MA-00892-00 | SQA-Vision Sperm Quality Analyzer | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | |
| 16 | 07290012140167 | 0700 | 0700 | QwikCheck Test Strips | M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD. | |
| 17 | 06944904084374 | 115-041604-00 | 0.5ml tube adpater | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
| 18 | 06944904084367 | 115-041599-00 | Tube rack module | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
| 19 | 06944904052113 | BC-5390 | Auto Hematology Analyzer BC-5390 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
| 20 | 06944904027883 | BC-3600 | Auto Hematology Analyzer(FDA) BC-3600 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
| 21 | 05999883586716 | ABACUS 3CP | A3CPC-1 | The Abacus 3 Cap Piercer (Abacus 3CP) is a fully automated, bench top hematology The Abacus 3 Cap Piercer (Abacus 3CP) is a fully automated, bench top hematology cell counter, is a device used to identify one or more of the formed elements of the blood. The Diatron Abacus 3 CP System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM#, MID%, MID#, GRA%,GRA#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV in EDTA anti-coagulated venous whole blood samples. | ABACUS 3CP Hematology Analyzer | DIATRON MEDICINAI INSTRUMENTUMOK LABORATORIUMI DIAGNOSZTIKAI FEJLESZTO-GYARTO ZARTKORUEN MUKODO RESZVENYTARSASAG |
| 22 | 05999883586228 | Abacus 5 | A5US-1 | Abacus 5 is an automated differential cell counter device used to identify one o Abacus 5 is an automated differential cell counter device used to identify one or more of the formed elements of the blood. The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood samples:WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV,MCH, MCHC, RDWcv, RDWsd, PCT, PDWcv, PDWsd, PLT, MPV, PLCC, and PLCR. | Abacus 5 Hematology Analyzer | DIATRON MEDICINAI INSTRUMENTUMOK LABORATORIUMI DIAGNOSZTIKAI FEJLESZTO-GYARTO ZARTKORUEN MUKODO RESZVENYTARSASAG |
| 23 | 05714183000010 | CX02 | CX02 | The Dextramer® CMV Kit comprises :;HLA-A*0101 / VTEHDTLLY / PE; HLA-A*0201 / NLV The Dextramer® CMV Kit comprises :;HLA-A*0101 / VTEHDTLLY / PE; HLA-A*0201 / NLVPMVATV / PE; HLA-B*0702 / TPRVTGGGAM / PE; HLA-B*0801 / ELRRKMMYM / PE;HLA-B*3501 / IPSINVHHY / PE Negative control / PE; Anti-CD8/FITC; Anti-CD3/PerCP; Anti-CD4/PE The Dextramer CMV Kit accurately enumerates CMV-specific T cells in blood samples. Dextramer® CMV Kit is a semi-quantitative assay intended for the identification and enumeration of cytomegalovirus (CMV)-specific CD8+ T cells in anticoagulated (Na Heparin) whole blood specimens by flow cytometry. Dextramer® CMV Kit is indicated for assessment of CMV-specific immune status and risk of CMV reactivation in adult human stem cell transplant patients following immunosuppression and used in conjunction with other laboratory and clinical findings. The kit cannot be used to measure CMV infection or disease. | Dextramer CMV Kit | IMMUDEX APS |
| 24 | 05700572028499 | X0955 | Negative Control Mouse IgG1/RPE-Cy5, Clone DAK GO-1 | Negative Control Mo IgG1/RPE-Cy5, Cl DAK-GO1 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 25 | 05700572028482 | X0928 | Negative Control Mouse IgG1/RPE, Clone DAK-GO1 | Negative Control Mo IgG1/RPE, Cl DAK-GO1 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 26 | 05700572028475 | X0927 | Negative Control Mouse IgG1/FITC, Clone DAK-GO1 | Negative Control Mo IgG1/FITC, Cl DAK-GO1 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 27 | 05700572028468 | R0808 | Monoclonal Mouse Anti-Human CD19/RPE, Clone HD37 | Mono Mo A-Hu CD19/RPE, Cl HD37 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 28 | 05700572028451 | R0806 | Monoclonal Mouse Anti-Human CD8/RPE, Clone DK25 | Mono Mo A-Hu CD8/RPE, Cl DK25 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 29 | 05700572028444 | R0805 | Monoclonal Mouse Anti-Human CD4/RPE, Clone MT310 | Mono Mo A-Hu CD4/RPE, Cl MT310 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 30 | 05700572028406 | FR868 | MultiMix Dual-Colour Reagent Anti-Human, CD4/FITC Anti-Human CD8/RPE | MultiMix Dual-Colour Reagent A-Hu CD4/FITC, A-Hu CD8/RPE | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 31 | 05700572028390 | FR866 | MultiMix Dual-Colour Reagent Anti-Human CD3/FITC Anti-Human CD19/RPE | MultiMix Dual-Colour Reagent A-Hu CD3/FITC A-Hu CD19/RPE | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 32 | 05700572028383 | FR700 | MultiMix Dual-Colour Reagent Anti-Human CD45/FITC Anti-Human CD14/RPE | MultiMix Dual-Colour Reagent A-Hu CD45/FITC A-Hu CD14/RPE | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 33 | 05700572028369 | F0766 | Monoclonal Mouse Anti-Human CD4/FITC, Clone MT310 | Mono Mo A-Hu CD4/FITC, Cl MT310 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 34 | 05700572028352 | C7067 | Monoclonal Mouse Anti-Human CD3/RPE-Cy5, Clone UCHT1 | Mono Mo A-Hu CD3/RPE-Cy5, Cl UCHT1 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 35 | 05700572028345 | C7066 | Monoclonal Mouse Anti-Human CD19/RPE-Cy5 Clone HD37 | Mono Mo A-Hu CD19/RPE-Cy5, Cl HD37 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 36 | 05700572028161 | R0810 | Monoclonal Mouse Anti-Human CD3/RPE, Clone UCHT1 | Mono Mo A-Hu CD3/RPE, Cl UCHT1 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 37 | 05700572028154 | F0818 | Monoclonal Mouse Anti-Human CD3/FITC, Clone UCHT1 | Mono Mo A-Hu CD3/FITC, Cl UCHT1 | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
| 38 | 04987562490110 | CT129514 | Automated Hematology Analyzer XW-100 | Automated Hematology Analyzer XW-100 | SYSMEX CORPORATION | |
| 39 | 04987562434572 | BD634545 | Automated Hematology Analyzer XN-L series XN-550 | Automated Hematology Analyzer XN-L series XN-550 | SYSMEX CORPORATION | |
| 40 | 04987562434565 | BQ391107 | Automated Hematology Analyzer XN-L series XN-530 | Automated Hematology Analyzer XN-L series XN-530 | SYSMEX CORPORATION | |
| 41 | 04987562434558 | BM392756 | Automated Hematology Analyzer XN-L series XN-450 | Automated Hematology Analyzer XN-L series XN-450 | SYSMEX CORPORATION | |
| 42 | 04987562434541 | CL032175 | Automated Hematology Analyzer XN-L series XN-430 | Automated Hematology Analyzer XN-L series XN-430 | SYSMEX CORPORATION | |
| 43 | 04987562434534 | AW618382 | Automated Hematology Analyzer XN-L series XN-350 | Automated Hematology Analyzer XN-L series XN-350 | SYSMEX CORPORATION | |
| 44 | 04987562434527 | CX851950 | Automated Hematology Analyzer XN-L series XN-330 | Automated Hematology Analyzer XN-L series XN-330 | SYSMEX CORPORATION | |
| 45 | 04987562432615 | CS297931 | XN-11 Complete | Automated Hematology Analyzer XN series XN-11 | SYSMEX CORPORATION | |
| 46 | 04987562429219 | AR408878 | Automated Hematology Analyzer XP-300 | Automated Hematology Analyzer XP series XP-300 | SYSMEX CORPORATION | |
| 47 | 04987562424221 | AE797961 | Automated Hematology Analyzer XN series XN-20 | Automated Hematology Analyzer XN series XN-20 | SYSMEX CORPORATION | |
| 48 | 04987562424214 | AP795756 | XN-10 Complete | Automated Hematology Analyzer XN series XN-10 | SYSMEX CORPORATION | |
| 49 | 04987562412860 | BB046392 | XS-1000iC Complete | Automated Hematology Analyzer XS series XS-1000iC | SYSMEX CORPORATION | |
| 50 | 04987562406807 | 05342311 | Sysmex XS-1000i™ Automated Hematology Analyzer | Automated Hematology Analyzer XS series XS-1000i | SYSMEX CORPORATION |