Abbott Diagnostics Korea Inc.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED FDA SRN KR-MF-000025193 FEI 3015883679
- Devices
- 160
- Registrations
- EUDAMED·FDA
- FDA recalls
- 0
DeviceDevice · Authorizations Verified Status Regime Registry Class
Bioline™ Syphilis 3.0 Ref AF06FK11PK
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNxTek™ Eliminate Malaria Pf Ref 05FK140
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Dengue NS1 Ag Ref AF11FK50PK
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f/P.v Ref 05FK82
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNxTek™ Eliminate Malaria Pf Ref 05FK143
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUroColor 11 Ref AF10UK11AMV
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Dengue NS1 Ag Ref AF11FK50H
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPanbio Dengue IgG Indirect ELISA Ref 01PE30
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUroColor 10 Ref AF10UK10JE
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Dengue IgG/IgM Ref AF11FK10PT
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Dengue IgG/IgM Ref AF11FK10E
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Dengue NS1 Ag Ref AF11FK50AMP
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Influenza Ultra Ref AF19FK13B
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Syphilis 3.0 Ref AF06FK11I
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNxTek™ Malaria Pf Ref 05FK144
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f/P.v Ref AF05FK80Q
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPanbio™ Dengue Early Rapid Ref AF01PF20PT
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPanbio™ Dengue IgG Indirect ELISA Ref 01PE30
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Cholera Ag O1/O139 Ref AF44FK30PK
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Syphilis Fast 3.0 Ref 06FK11
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f/Pan Ref 05FK61
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Syphilis 3.0 Ref 06FK10
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Dengue Duo Ref AF11FK46AMP
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUroColor 2K Ref AF10UK02KAU
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPanbio Dengue IgM Capture ELISA Ref F01PE21B
Withdrawn Regimes: CE IVDD, withdrawn Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f/Pan Ref 05FK60
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNxTek™ Eliminate Malaria Pf Ref 05FK140
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f Ref AF05FK50AI
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPanbio™ Dengue IgG Capture ELISA Ref AF01PE10PT
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ H.pylori Ref 04FK10
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f/Pan Ref 05FK62
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSD BIOLINE H.pylori Ag Ref 04FK20
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Rotavirus Ref AF14FK10PT
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Influenza Antigen Ref AF19FK12AMV
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNxTek™ Eliminate Malaria Pf Ref 05FK140
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPanbio™ Leptospira IgM ELISA Ref AF02PE10PT
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f Ref 05FK52
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Dengue Duo Ref AF11FK45PT
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f/Pan Ref AF05FK63AMV
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSD BIOLINE H.pylori Ref 04FK10
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Dengue Duo Ref AF11FK46PK
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f/P.v Ref 05FK83
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Dengue NS1 Ag Ref AF11FK50G
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f/Pan Ref AF05FK63PT
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Syphilis 3.0 Ref 06FK10
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNxTek™ Eliminate Malaria Pf Ref 05FK142
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Tsutsugamushi Ref AF18FK10AMP
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUroColor 4S Ref AF10UK04SAU
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f (HRP2/pLDH) Ref 05FK93
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBioline™ Malaria Ag P.f Ref AF05FK50AH
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Rows 51-100 of 160
Showing 51-100 of 160
Company details
- EUDAMED SRN
- KR-MF-000025193
- FDA FEI number
- 3015883679
- EUDAMED status
- Active
- EUDAMED registered name
- Abbott Diagnostics Korea Inc.
- EUDAMED abbreviated name
- ADK
- Registered address
- 65, Borahagal-ro, 17099, Yongin-si, Gyeonggi-do, South Korea
- Website
- www.abbott.com
- linkedin.com/company/1612
- facebook.com/Abbott
- [email protected]
- Phone
- +82 31 899 2800
- PRRC contact
- Hemant Vekaria(public in EUDAMED)