The NHLS HTA Unit List of Prequalified IVD Products
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1 The NHLS HTA Unit List of Prequalified IVD Products Year Type of evaluation Project Number IVD Technology Name Supplier Manufacturer 2014 Instrument Upgrade 2014 Instrument Upgrade HTP Liason XL Humor Diagnostica Diasorin HTP14-19 Leica ASP6025 SMM Instruments (Pty )LTD Leica Biosystems *2015 New Instrument HTP C Maglumi 2000: FSH, PCT, Cortisol, Ferritin The Scientific Group Snibe Diagnostic *2015 New Instrument HTP15-02 The Clinitek advantus Siemens Pty (LTD) Siemens Pty (LTD) Inc New Instrument HTP13-06 The BioPlex 2200 Bio_rad South Africa Bio_rad Laboratories inc 2015 New Instrument HTP13-47 Easy G26 Separation Scientific SA (Pty )LTD Interlab 2015 New Instrument HTP13-29 Benchmark Special Stainer: ABPAS, AB, Fungi, FE, Jones, AFB, PAS, DPAS, Trichome, CR, Giemsa Roche Products PTY(LTD) Ventana Medical Systems, inc 2015 New Instrument HTP RP500 (Blood gas) Siemens Pty (LTD) Siemens Pty (LTD) 2015 New Instrument HTP13-48B Capillarys 2 Flex Piercing (Serum as well as Urine protein electrophoresis) Ilex SA (PTY)Ltd 2015 New Instrument HTP13-35 CINtec PLUS (on the Benchmark XT system). Roche Products (PTY)Ltd Ventana Medical Systems, inc Sebia 2014 New Instrument HTP A Euroblaster Euroimmune Euroimmune 2014 New Instrument HTP Swing and Saxo ID reader Biorad Biorad 2014 New Instrument HTP13-02 Microbiology automated systems Siemens Pty (LTD) Siemens The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 1 of 6
2 2014 New Instrument HTP13-23 Bond III SMM Instruments (PTY)Ltd Leica Biosystems 2014 New Instrument HTP13-26 Aptima HPV Ilex SA Hologic Gen probe 2014 New Instrument HTP13-31A Thinprep T2000 Separation Scientific SA (Pty )LTD Hologic Gen probe 2014 New Instrument HTP13-34 COBAS 4800 HPV test (on the Benchmark XT system). Roche Products (Pty )LTD Roche Diagnostics 2014 New Instrument HTP13-36 Real time m2000 system HPV Abbott Laboratories (Pty )LTD Abbott Laboratories 2014 New Instrument HTP13-38 Xpert HPV assay for use with the GeneXpert system Cepheid Cepheid 2014 New Instrument HTP13-39 Digene HC2 High risk HPV DNA test Whitehead Scientific Qiagen Gaithersburg 2014 New Instrument HTP13-44 Biovue Technology The Scientific Group Ortho Clinical Diagnostics 2014 New Instrument HTP13-48 Capillarys 2 Flex Piercing Ilex SA Sebia 2014 New Instrument HTP13-31B Compass staining machine Separation Scientific SA (Pty )LTD Hologic Gen probe 2014 New Instrument HTP13-31C Thinprep T5000 Separation Scientific SA (Pty )LTD Hologic Gen probe 2014 New Instrument HTP13-31D Thinprep Imaging System and I-square Separation Scientific SA (Pty )LTD Hologic Gen probe 2014 New Instrument HTP13-31E Thinprep T-5 Autoloader S Separation Scientific SA (Pty )LTD Hologic Gen probe 2013 New Instrument HTP SG Vacutainer tubes The Scientific Group The Scientific Group 2013 New Instrument HTP ACL TOP 300/ 500 Beckman Coulter Instrumentation 2aboratory (Part of Werfen Group 2013 New Instrument HTP EASY RA Medical Electronic Distributors (Pty) LTD, (M.E.D) Medica The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 2 of 6
3 2013 New Instrument HTP Stratus Siemens Pty (LTD) Siemens 2013 New Instrument HTP Sysmex 500i Roche Products (Pty )LTD Sysmex 2013 New Instrument HTP Symex XN 2000 Roche Products (Pty )LTD Sysmex 2013 New Instrument HTP13-12 iq 200 System Beckman Coulter Iris International 2013 New Instrument HTP13-15 Architect c4000 Abbott Laboratories Copan Italia S.p.A 2013 New Instrument HTP13-32A Therascreen RGQ mutation assays Kras Whitehead Scientific QiaGen N.V New Instrument HTP13-32B Therascreen RGQ mutation assays Braf Whitehead Scientific QiaGen N.V New Instrument HTP Mindray BC-5800 Separation Scientific SA (Pty )LTD Mindray 2012 New Instrument HTP Tosoh G8 HBA1c Replamed Tosoh Bioscience 2012 New Instrument HTP Sysmex 2100 XI Roche Products (Pty )LTD Sysmex 2012 New Instrument HTP BactAlert FA Plus Biomerieux South Africa Biomerieux 2015 Reagent Upgrade HTP15-27 Estradiol Roche Products (Pty )LTD Roche Diagnostics GmbH 2015 Reagent Upgrade HTP14-18 Tina Quant Lipoprotein Gen.2 Roche Products (Pty )LTD Roche Diagnostics GmbH 2015 Reagent Upgrade HTP15-15 Advia 1800 concentrated ALB, CRE, AST, ALT, Phos Siemens Pty (LTD) Siemens Pty (LTD) Inc 2015 Reagent Upgrade HTP14-36 BILT Gen 3 on C111 Roche Products (Pty )LTD Roche Diagnostics GmbH 2015 Reagent Upgrade HTP14-40 Vitamin D Total Roche Products (Pty )LTD Roche Diagnostics GmbH The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 3 of 6
4 2014 Reagent Upgrade HTP13-40 Free T4 Assay on Architect Abbott Laboratories (Pty )LTD Abbott Laboratories 2014 Reagent Upgrade HTP13-41 Anti HCV Architect Abbott Laboratories (Pty )LTD Abbott Laboratories 2014 Reagent Upgrade HTP14-01 Tina Quant HBA1c Roche Products (Pty )LTD Roche Diagnostics 2014 Reagent Upgrade HTP14-14 Access AccuTnI+3 assay Beckman Coulter Beckman Coulter 2014 Reagent Upgrade HTP14-15 Access Total BHcG (5 th IS) Beckman Coulter Beckman Coulter 2013 Reagent Upgrade HTP Calcium GEN2 reagent Roche Products (Pty )LTD Roche Diagnostics 2013 Reagent Upgrade HTP Calcium reagent Roche Products (Pty )LTD Roche Diagnostics 2013 Reagent Upgrade HTP13-10 Tropinin I Siemens Pty (LTD) Siemens 2013 Reagent Upgrade HTP13-27 ALPi reagent and ALPi Calibrator Siemens Pty (LTD) Siemens Pty (LTD) 2012 Reagent Upgrade HTP ALTI reagent Siemens Pty (LTD) Siemens Pty (LTD) *2015 New reagent HTP15-16 ADVIA Centaur Cortisol assay Siemens Pty (LTD) Siemens Pty (LTD) Products GmbH *2015 New reagent HTP14-17 Syphillis Total Ab Roche Products PTY(LTD) Roche Diagnostics 2015 New reagent HTP13-28 Vitek 2 Biomerieux South Africa Biomerieux 2015 New Reagent HTP13-51 Alpha-Tec System-MTB Decontamination/ Digestion systems Cepheid Alpha-Tec Systems Inc New Reagent HTP B Euroline Allergy strips Euroimmune Euroimmune 2014 New Reagent HTP13-09 RBC FOLATE reagent on Cobas e611 Roche Products (Pty )LTD Roche Diagnostics The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 4 of 6
5 2014 New Reagent HTP13-30 CMV ON Cobas Ampliprep/ Taqman Roche Products (Pty )LTD Roche Diagnostics 2014 New Reagent HTP14-25 Real time m2000 system CMV Abbott Laboratories (Pty )LTD Abbott Laboratories 2013 New Reagent HTP HIV LFC Atomo Diagnostics Atomo Diagnostics 2013 New Reagent HTP CI8200 HBA1C Abbott Laboratories (Pty )LTD Abbott Laboratories *2015 POCT Instrument HTP14-21 BD FACSPresto The Scientific Group BD Biosciences 2015 POCT Instrument HTP13-04 Afinion: Lipid panel Alere Healthcare Axis Shield 2015 POCT Instrument HTP15-19 TOX/See Rapid Urine Drug Screen Tests Bio-Rad Laboratories (Pty )LTD Biorad Laboratories, Inc 2013 POCT Instrument HTP AQT90 Radiometer Radiometer 2013 POCT Instrument HTP Genius HIV Biorad Beckman Coulter 2013 POCT Instrument HTP Afinion: HBA1c Alere Healthcare Axis Shield 2012 POCT Instrument HTP Triage : D-Dimer Test Alere Healthcare Alere Healthcare 2014 POCT RDT HTP14-31 Biotracer HIV1/2 Rapid card Fulloutput1305 cc Bio Focus Co., Ltd POCT RDT HTP14-28 HIV 1,2 RDT Clinihealth International Cork Technology 2014 POCT RDT HTP14-09 RightSign HIV 1.2 O Rapid test cassette NH Medicals Hangzhou Biotest Biotech, Co.Ltd 2013 POCT RDT HTP Parahit f Ver Device & Parahit Total Ver Device. Span Diagnostics Ltd Span Diagnostics Ltd 2013 POCT RDT HTP Cryptococcus LFC Hain Lifescience Immuno-Mycologics Inc (Immy) The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 5 of 6
6 2012 POCT RDT HTP RPR Chromatest Span Diagnostics Ltd Span Diagnostics Ltd 2012 POCT RDT HTP Signal HIV Span Diagnostics Ltd Haemotec 2012 POCT RDT HTP Blood Grouping antisera Span Diagnostics Ltd Span Diagnostics Ltd 2012 POCT RDT HTP OneStep Anti-Syphilis Cassette Test Humor Diagnostica Cortez Diagnostics The NHLS HTA Unit List of Prequalified IVD Products Effective: 3 Aug 2015 Page 6 of 6
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