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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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Retroviruses rt & poc
Retroviruses rt & poc
W01050903
45 devices
Subcategories
4
W0105090301
HIV 1 - rt & poc
0
devices
W0105090302
HIV 1 / 2 - rt & poc
39
devices
W0105090303
HIV ag/ab combi - rt & poc
1
device
W0105090399
Retroviruses - rt & poc - other
5
devices
Devices
OraQuick HIV Self-Test
OraSure Technologies, Inc.
·
,
United States
IVD Annex II List A
CE/IVDD
OraQuick HIV Self-Test
OraSure Technologies, Inc.
·
,
United States
IVD Annex II List A
CE/IVDD
OraQuick HIV Self-Test
OraSure Technologies, Inc.
·
,
United States
IVD Annex II List A
CE/IVDD
Hivfind
Meril Diagnostics Pvt. Ltd.
·
,
India
Class D
CE/IVDR
×2
Active
Valid to Sep 2028
OraQuick HIV Self-Test
OraSure Technologies, Inc.
·
,
United States
IVD Annex II List A
CE/IVDD
MP Diagnostics MULTISURE HIV Rapid Test
MP Biomedicals Asia Pacific Pte Ltd
·
,
Singapore
IVD Annex II List A
CE/IVDD
Anti-HIV 1/2 Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD Annex II List A
CE/IVDD
Meriscreen
Meril Diagnostics Pvt. Ltd.
·
,
India
Class D
CE/IVDR
×2
Active
Valid to Sep 2028
OraQuick HIV Self-Test
OraSure Technologies, Inc.
·
,
United States
IVD Annex II List A
CE/IVDD
Artron Human lmmunodeficiency Virus 1/2 (HMl2l Antibody Test
Artron Laboratories Inc.
·
,
Canada
IVD Annex II List A
CE/IVDD
Anti-HIV 1/2 Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD Annex II List A
CE/IVDD
Anti-HIV 1/2 Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD Annex II List A
CE/IVDD
Acmex Human Immunodeficiency Virus 1/2 (HIV1/2) Antibody Test
Artron Laboratories Inc.
·
,
Canada
Class D
CE/IVDR
×2
Active
Valid to Aug 2029
Anti-HIV 1/2 Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD Annex II List A
CE/IVDD
CupiKIT
Cupid Limited
·
,
India
Class D
CE/IVDR
×2
Active
Valid to Oct 2030
Anti-HIV 1/2 Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD Annex II List A
CE/IVDD
RightSign
HangZhou Biotest Biotech Co., Ltd.
·
,
China
IVD Annex II List A
CE/IVDD
HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Device (Whole Blood …
Abon Biopharm(Hangzhou) Co., Ltd
·
,
China
IVD Annex II List A
CE/IVDD
Hantavirus IgG/IgM Antibody Rapid Test Kit
Shenzhen Reagent Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Hantavirus IgG/IgM Antibody Rapid Test Kit
Shenzhen Reagent Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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