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In vitro diagnostic medical devices
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Infectious diseases
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Infectious immunology - rapid tests & point of care
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Bacteriology - rt & poc
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Syphilis - rt & poc
Syphilis - rt & poc
W0105090105
86 devices
CupiKIT
Cupid Limited
·
,
India
Class C
CE/IVDR
2025-IVDR/QS-008/A
Active
Valid to Oct 2030
Syphilis Ab Rapid Test Cassette (Serum/Plasma)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Anti-Syphilis Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD General
CE/IVDD
Lyher
Hangzhou Laihe Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
Lyher
Hangzhou Laihe Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
Lyher
Hangzhou Laihe Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
Rpr-Dat
Diesse Diagnostica Senese S.P.A
·
,
Italy
Class C
CE/IVDR
Acmex Treponema Pallidum (TP) Antibody Test
Artron Laboratories Inc.
·
,
Canada
Class C
CE/IVDR
×2
Active
Valid to Aug 2029
Syphilis Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class C
CE/IVDR
TruVue
BioFynder Limited
·
,
United Kingdom
IVD General
CE/IVDD
Syphilis Ab Rapid Test Strip (Serum/Plasma)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Determine
Abbott Diagnostics Medical Co., Ltd.
·
,
Japan
IVD General
CE/IVDD
Syphilis Serum Test
Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Syphilis Ab Rapid Test Cassette (Serum/Plasma)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
RPR Carbon bez kontroli 100 ozn.
BioMaxima Spółka Akcyjna
·
,
Poland
Class C
CE/IVDR
Syphilis Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class C
CE/IVDR
Syphilis Ab Combo Rapid Test
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Artron One Step Treponema Pallidum (TP) Antibody Test
Artron Laboratories Inc.
·
,
Canada
IVD General
CE/IVDD
Syphilis Rapid Test
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
Class C
CE/IVDR
Syphilis FIA
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD General
CE/IVDD
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