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Certificate for technology
  • List
  • Institute
  • Date
HT certificate
New Excellent Technology (NET)
New Excellent Product(NEP)

Ministry of Health & Welfare
Ministry of Education, Science and Technology
Ministry of commerce, Industry &
Energy The Republic of Korea
Apr. 15 2009
Jul. 05 2006
Apr. 06 2006

Certificate for system
  • List
  • Institute
  • Date
ISO9001:2008
ISO13485:2003
Canada CMDCAS (ISO13485:2003)
BSI Group - British Standards Institution
BSI Group - British Standards Institution
BSI Group - British Standards Institution
Dec. 05 2009
May. 01 2007
Oct. 13 2008
CE Certificate (CE-IVD)
  • Respiratory Pathogen Detection Products
  • Cat. No.
  • Institute
  • Data
Anyplex™ II RV16 Detection
Anyplex™ FluA/B Typing Real-time Detection
Anyplex™ FluA/New H1N1 Real-time Detection
Magicplex™ RV Panel Real time test
- Magicplex™ RV Panel Amplification
- Magicplex™ RV Panel Real-time Detection
- Magicplex™ FluA Real-time Subtyping
Seeplex® RV15 OneStep ACE Detection
RV7G01Y
RV7310X
RV7300X

RV8000Y
RV8901Y
RV8301Y
RV6F01Y
CE
CE
CE
CE



CE
Dec. 23 2011
Oct. 21 2011
Oct. 07 2011
Jan. 11 2011



Sep. 24 2010
Seeplex® Influenza A/B OneStep Typing
Seeplex® RV15 ACE Detection
Seeplex® FluA/New H1N1 ACE Detection
Seeplex® FluA ACE Subtyping
Seeplex® PndumoBacter ACE Detection
Seeplex® RV/PB18 ASE Detection
Seeplex® RV5 ACE Screening
Seeplex® RV12 ACE Detection
Seeplex® RV12 Detection
Seeplex® RV6 Detection
Seeplex® RV7 Detection
RV6520X
RV6F00Y
SI6100Y
RV6400Y
PB1610Y
RP5J10Y
RV6550Y
RV6C00Y
RV1211
RV2210
RV3210
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
Oct. 02 2009
Sep. 11 2009
Sep. 11 2009
Sep. 08 2009
Jun. 30 2008
Jun. 30 2008
Jun. 30 2008
Sep. 28 2007
Sep. 28 2007
Sep. 28 2007
Sep. 28 2007
  • STD Pathogen Detection Products
  • Cat. No.
  • Institute
  • Date
Seeplex® STI Master panel 1
Anyplex™ CT/NG Real-time Detection
Magicplex™ STI 1 Real-time Test
- Magicplex™ STI 1 Amplification
- Magicplex™ CT/NG Real-time Detection
- Magicplex™ MG/MH/UU Real-time Detection
SD6511Y
SD7200Y

SD8000Y
SD8201Y
SD8301Y
CE0086
CE0086
CE

CE0086
CE
Aug. 30 2011
Jan.
17 2011
Jan. 17 2011
Oct. 21 2010
Jan. 17 2011
Oct. 21 2010
Seeplex® STD4D ACE Detection
Seeplex® STD6 ACE Detection
Seeplex® HPV/STD4 ACE Screening
SD6400Y
SD6600Y
SH1400Y
CE
CE0086
CE0086
Jul. 28 2010
Jul. 21 2008
Jul. 21 2008
  • HPV Detection Products
  • Cat. No.
  • Institute
  • Date
Magicplex™ HPV 16/18 Real-time Test
- Magicplex™ HPV 16/18 Amplification
- Magicplex™ HPV 16/18 Real-time Detection

HP8000Y
HP8201Y
CE
Oct. 08 2010
Seeplex® HPV4A ACE Screening
Seeplex® HPV6 ACE Genotyping
Seeplex® HPV/STD4 ACE Screening
HP6401Y
HP1511Y
SH1400Y
CE
CE
CE0086
Jun. 12 2009
Mar. 03 2009
Jul. 21 2008
  • TB Detection Products
  • Cat. No.
  • Institute
  • Date
Anyplex™ plus MTB/NTM/MDR-TB Detection

Magicplex™ MTB Real-time Test
Anyplex™
MTB/NTM Real-time Detection
Seeplex® MTB ACE Detection
Seeplex® MTB Nested ACE Detection
Seeplex® MTB/BCG ACE Detection
TBP7200X
TBP7201Z
TB8101Y
TB7200X
TB6100Y
TB2110Y
TB3110Y
CE
CE
CE
CE
CE
CE
CE
Nov. 17 2011
Nov. 17 2011
Aug. 16 2010
Jul. 12 2010
May. 19 2008
May. 19 2008
May. 19 2008
  • Meningitis bacteria and virus Detection Product
  • Cat. No.
  • Institute
  • Date
Seeplex® Meningitis ACE Detection
- Seeplex® Meningitis ACE Detection
- Seeplex® Meningitis-V1 ACE Detection
- Seeplex® Meningitis-V2 ACE Detection
- Seeplex® Meningitis-B ACE Detection

MG6000Y
MG6611Y
MG6111Y
MG6501Y
CE0086

Nov. 26 2009
Nov. 26 2009
Jun. 10 2009
Jun. 10 2009
  • Diarrhea bacteria and virus Detection Product
  • Cat. No.
  • Institute
  • Date
Seeplex® Diarrhea ACE Detection
- Seeplex® Diarrhea ACE Detection
- Seeplex® Diarrhea-V ACE Detection
- Seeplex® Diarrhea-B1 ACE Detection
- Seeplex® Diarrhea-B2 ACE Detection

DR6000Y
DR6411Y
DR6501Y
DR6502Y
CE
Jun. 10 2009
Jun. 10 2009
Jun. 10 2009
Jun. 10 2009
  • HSV1 & HSV2 Detection Product
  • Cat. No.
  • Institute
  • Date
Magicplex HSV 1/2 Real-time Detection
Seeplex® HSV2 ACE Detection
HS8201Y
HS6200Y
CE
CE
Oct. 25 2010
2009.11.27
  • Drug Resistance Detection Product
  • Cat. No.
  • Institute
  • Date
Magicplex VanR Real-time Test
- Magicplex™ VanR Amplification
- Magicplex™ VanR Real-time Detection

VR8000X
VR8301X
CE
Oct. 15 2010
  • Sepsis Detection Product
  • Cat. No.
  • Institute
  • Date
MagicplexSepsis Real-time Test
- Magicplex™ Sepsis Amplification
- Magicplex™ Screening Real-time Detection
- Magicplex™ Sepsis ID 1~9 Real-time Detection
SE8000Y
SE8T01Y
SE8301Y~SE8309Y
CE 2011.04.11
  • Somatic Mutation Detection Product
  • Cat. No.
  • Institute
  • Date
Anyplex™ BRAF V600E Real-time Detection BR7100Y
CE Sep. 24 2010
Health Canada Approval
  • Product
  • Cat. No.
  • Institute
  • Date
Seeplex® Influenza A/B OneStep Typing
Seeplex® RV15 ACE Detection
Seeplex® RV15 OneStep ACE Detection
Seeplex® Diarrhea-V ACE Detection
Seeplex® RV7 Detection
Seeplex® RV5 ACE Screening
Seeplex® RV12 ACE Detection

RV6520X
RV6F00Y
RV6F01X
DR6411Y
RV3210
RV6550Y
RV6C00Y
HealthCanada
HealthCanada
HealthCanada
HealthCanada
HealthCanada
HealthCanada
HealthCanada
Nov. 15 2010
Jul. 23 2010
Jul. 23 2010
Dec. 03 2009
Jun. 24 2009
Nov. 04 2008
Nov. 04 2008
GH- Goods of Health Mark Approval
  • Product
  • Cat. No.
  • Institute
  • Date
Seeplex® RV5 ACE Screening
Seeplex® RV6 Detection
Seeplex® RV7 Detection
Seeplex® RV12 ACE Detection
Seeplex® RV15 ACE Detection
Seeplex® FluA ACE Subtyping
Seeplex® Influenza A/B OneStep Typing
Seeplex® STI Master ACE Detection(panel 1~5)
Seeplex® STD6 ACE Detection
Seeplex® STD6B ACE Detection
Seeplex® STD 4D ACE Detection
Seeplex® STD4 ACE Detection
Seeplex® HPV 4A ACE Screening
Seeplex® HPV6 ACE Genotyping
RV6550Y
RV2210
RV3210
RV6C00Y
RV6F00Y
RV6400Y
RV6520X
SD6510X
SD6600Y
SD6601Y
SD6401Y
SD6400Y
HP6401Y
Korea
Health Industry
Development
Institute
Dec. 08 2010
Dec. 08 2010
Dec. 08 2010
Dec. 08 2010
Dec. 08 2010
Dec. 08 2010
Dec. 08 2010
Dec. 30 2011
Dec. 30 2011
Dec. 30 2011
Dec. 30 2011
Dec. 30 2011
Dec. 30 2011
Dec. 30 2011
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