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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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Hepatitis viruses - rt & poc
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Hbsag - rt & poc
Hbsag - rt & poc
W0105090201
24 devices
Devices
HBsAg Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
MP Diagnostics HBsAg ELISA 4.1
MP Biomedicals Asia Pacific Pte Ltd
·
,
SG
IVD Annex II List A
CE/IVDD
HBsAg Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
Acmex Hepatitis B Surface Antigen (HBsAg) Test
Artron Laboratories Inc.
·
,
CA
Class D
CE/IVDR
2024-IVDR/QS-005/B
Active
Valid to Aug 2029
CE/IVDR
2024-IVDR/TD-005/B
Active
Valid to Aug 2029
Prueba Rápida de HBsAg en Casete
Hangzhou Alltest Biotech.Co., Ltd.
·
,
CN
IVD Annex II List A
CE/IVDD
HBsAg Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
HBsAg Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
MP Diagnostics HBsAg ELISA 4.1
MP Biomedicals Asia Pacific Pte Ltd
·
,
SG
IVD Annex II List A
CE/IVDD
HBsAg Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
HBsAg Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
HBsAg Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
HBsAg Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood +2 more)
Abon Biopharm(Hangzhou) Co., Ltd
·
,
CN
IVD Annex II List A
CE/IVDD
HBsAg Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
Artron Hepatitis B Virus Surface Antigen (HBsAg) Test
Artron Laboratories Inc.
·
,
CA
IVD Annex II List A
CE/IVDR
2024-IVDR/QS-005/B
Active
Valid to Aug 2029
CE/IVDR
2024-IVDR/TD-005/B
Active
Valid to Aug 2029
+1
authorizations
HBsAg Rapid Test Cassette
Hangzhou Alltest Biotech.Co., Ltd.
·
,
CN
IVD Annex II List A
CE/IVDD
HBsAg Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
HBsAg Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
CupiKIT
Cupid Limited
·
,
IN
Class D
CE/IVDR
2026-IVDR/QS-001/A
Active
Valid to Oct 2030
CE/IVDR
2026-IVDR/TD-001/A
Active
Valid to Oct 2030
Acmex HIV Ab, HBsAg & HCV Ab (3H) Combo Test (Acmex 3H Combo Test)
Artron Laboratories Inc.
·
,
CA
Class D
CE/IVDR
2024-IVDR/QS-008/B
Active
Valid to Aug 2029
CE/IVDR
2024-IVDR/TD-008/B
Active
Valid to Aug 2029
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