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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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HCV antibody -rt & poc
HCV antibody -rt & poc
W0105090202
21 devices
Devices
HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)
Healgen Scientific Limited Liability Company
·
,
US
IVD Annex II List A
CE/IVDD
Anti-HCV Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
Anti-HCV Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)
Abon Biopharm(Hangzhou) Co., Ltd
·
,
CN
IVD Annex II List A
CE/IVDD
Acmex Hepatitis C Virus (HCV) Antibody Test
Artron Laboratories Inc.
·
,
CA
Class D
CE/IVDR
2024-IVDR/QS-006/B
Active
Valid to Aug 2029
CE/IVDR
2024-IVDR/TD-006/B
Active
Valid to Aug 2029
OraQuick HCV Rapid Antibody Test
OraSure Technologies, Inc.
·
,
US
IVD Annex II List A
CE/MDR
HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)
Healgen Scientific Limited Liability Company
·
,
US
IVD Annex II List A
CE/IVDD
Anti-HCV Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
Anti-HCV Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
Anti-HCV Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
Anti-HCV Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
Anti-HCV Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
OraQuick HCV Rapid Antibody Test
OraSure Technologies, Inc.
·
,
US
IVD Annex II List A
CE/MDR
Anti-HCV Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
RightSign
HangZhou Biotest Biotech Co., Ltd.
·
,
CN
IVD Annex II List A
CE/IVDD
Artron Hepatitis C Virus (HCV) Antibody Test
Artron Laboratories Inc.
·
,
CA
IVD Annex II List A
CE/IVDR
2024-IVDR/QS-006/B
Active
Valid to Aug 2029
CE/IVDR
2024-IVDR/TD-006/B
Active
Valid to Aug 2029
+1
authorizations
Anti-HCV Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
Anti-HCV Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
TR
IVD Annex II List A
CE/IVDD
OraQuick HCV Rapid Antibody Test
OraSure Technologies, Inc.
·
,
US
IVD Annex II List A
CE/MDR
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