Registration & Approval

Certified System

List Institute Date
ISO13485:2016 BSI 2017.10.13
ISO9001:2015 BSI 2016.04.30

CE Certified (CE-IVD)

Respiratory Pathogen Detection Products Cat. No.
Seeplex® RV7 Detection RV3210
Seeplex® RV15 ACE Detection RV6F00Y
Seeplex® RV15 OneStep ACE Detection (V1.1) RV6F01Y
Seeplex® PneumoBacter ACE Detection (V3.0) PB1610Y
Anyplex™ FluA/B Typing Real-time Detection (V1.1) RV7310X
Anyplex™ II RV16 Detection (V1.1) RV7G01Y,X
Anyplex™ II RB5 Detection RB7500Y,X
Allplex™ Respiratory Panel 1 RP9801Y,X
Allplex™ Respiratory Panel 2 RP9802Y,X
Allplex™ Respiratory Panel 3 RP9601Y,X
Allplex™ Respiratory Panel 4 RP9803Y,X
Allplex™ RV Essential Assay RV9750X,Y
Allplex™ Respiratory Panel 1A RP9702X,Y
Allplex™ Respiratory Panel 4 Combi RP10171Y
STI Detection Products Cat. No.
Seeplex® STD6 ACE Detection (V2.0) SD6600Y
Seeplex® STI Master panel 1 (V2.0) SD6511Y
Seeplex® HSV2 ACE Detection HS6200Y
Anyplex™ CT/NG Real-time Detection (V3.1) SD7200Y
Anyplex™ II STI-7 Detection (V1.1) SD7700Y,X
Anyplex™ II STI-5 Detection SD7500Y,X
Anyplex™ II STI-7e Detection SD7701Y,X
Allplex™ STI Essential Assay SD9801Y,X
Allplex™ Genital ulcer Assay SD9802X,Y
Allplex™ Candidiasis Assay SD9803X.Y
Allplex™ Bacterial Vaginosis Assay SD9804X
Allplex™ CT/NG/MG/TV Assay SD9400X,Y
Allplex™ Bacterial Vaginosis plus Assay SD10159X
Allplex™ MG&AziR Assay SD10169Y, SD10170X
Allplex™ Vaginitis Screening Assay SD9750Y, X
Tuberculosis Detection Product Cat. No.
Seeplex® MTB Nested ACE Detection (V2.3) TB2110Y
Anyplex™ MTB/NTM Real-time Detection (V2.0) TB7200X
Anyplex™ plus MTB/NTM/MDR-TB Detection (V1.1) TBP7200X, TBP7201Z
Anyplex™ II MTB/MDR/XDR Detection TB7500Y
Anyplex™ II MTB/MDR Detection TB7301Y
Anyplex™ II MTB/XDR Detection TB7302Y
Anyplex™ MTB/NTMe Real-time Detection TB7202Y,X
Anyplex™ MTB/NTM combi TB7203Y,X
Allplex™ MTB/MDR/XDRe Detection TB10173Y, TB10174X
Allplex™ MTB/MDRe Detection TB9400Y, X
Allplex™ MTB/XDRe Detection TB9500Y, X
Sepsis Detection Product Cat. No.
Magicplex™ Sepsis Real-time Test SE8000Y
Meningitis Pathogen Detection Product Cat. No.
Seeplex® Meningitis ACE Detection (V2.0) MG6000Y
Seeplex® Meningitis-V2 ACE Detection (V2.0) MG6111Y
Seeplex® Meningitis-B ACE Detection (V2.0) MG6501Y
Seeplex® Meningitis-V1 ACE Detection (V2.0) MG6611Y
Allplex™ Meningitis-V1 Assay MG9700Y, X
Allplex™ Meningitis-V2 Assay MG9500Y, X
Allplex™ Meningitis-B Assay MG9600Y, X
Gastrointestinal Pathogen Cat. No.
Allplex™ GI-Virus Assay GI9701Y, X
Allplex™ GI-Bacteria(I) Assay GI9801Y, X
Allplex™ GI-Parasite Assay GI9703Y, X
Allplex™ GI-Bacteria(II) Assay GI9702Y, X
Seeplex® Diarrhea ACE Detection DR6000Y
Seeplex® Diarrhea-B2 ACE Detection DR6502Y
Seeplex® Diarrhea-B1 ACE Detection DR6501Y
Seeplex® Diarrhea-V ACE Detection DR6411Y
Allplex™ GI-Virus plus Assay GI10186Z, GI10187Y, GI10188X
Allplex™ GI-Helminth(I) Assay GI10189Z, GI10190Y, GI10191X
Others Cat. No.
Anyplex™ Thrombosis SNP Panel Assay TS7600X,Y
STARMag 48 x 8 Tissue Cartridge Kit 744300.4.TC384
STARMag 48 x 8 Virus Cartridge Kit 744800.4.VC384
STARMag 96 Tissue 744300.4.205875
STARMag 96 Virus 744800.4.205875
STARMag Universal Cartridge Kit 744300.4.UC384
Allplex™ Entero-DR Assay CR9700Y,X
Human Papillomavirus Cat. No.
Seeplex® HPV4A ACE Screening HP6401Y
Anyplex™ II HPV28 Detection (V2.0) HP7S00X
Anyplex™ II HPV HR Detection (V2.0) HP7E00X

Health Canada

List Cat. No.
Seeplex® STD6 ACE Detection SD6600Y
Seeplex® RV15 OneStep ACE Detection RV6F01X
Seeplex® RV15 ACE Detection RV6F00Y
Anyplex™ II RV16 Detection RV7G01Y
Allplex™ Respiratory Panel 1 RP9801Y
Allplex™ Respiratory Panel 2 RP9802Y,X
Allplex™ Respiratory Panel 3 RP9601Y,X
Allplex™ Respiratory Panel 5 RP9701Y,X
Allplex™ GI-Virus Assay GI9701Y,X
Allplex™ GI-Parasite Assay GI9703Y,X

GH- Goods of Health Mark Approval

List Cat. No.
Seeplex® STI Master ACE Detection(panel 1~5) SD6510X
Seeplex® STD6 ACE Detection SD6600Y
Seeplex® HPV 4A ACE Screening HP6401Y
Seeplex® HPV6 ACE Genotyping HP1511Y
Seeplex® STD6B ACE Detection SD6601Y
Seeplex® RV7 Detection RV3210
Seeplex® RV15 ACE Detection RV6F00Y
Seeplex® Influenza A/B OneStep Typing RV6520X
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