emdn_classification BACTERIOLOGY - RT & POC - OTHER Manufacturer:

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eudamed_udi Cryptococcus Rapid Test Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.

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eudamed_udi Legionella & S.pneumoniae Antigen Combo Rapid Test(Urine) Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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eudamed_udi Vibrio cholerae O1/O139 Antigen Rapid Test Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

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eudamed_udi Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Campylobacter Rapid Test Device – Feces Manufacturer: Rapid Labs Ltd

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eudamed_udi 20 Tests/Kit Manufacturer: Labnovation Technologies, Inc.

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eudamed_udi Typhoid IgG/IgM Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi Gonorrhea + Chlamydia Antigen Combo Test Cassette Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.

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eudamed_udi Rapid Tuberculosis Test Card-Serum Manufacturer: Xiamen Boson Biotech Co., Ltd.

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eudamed_udi Gonorrhea Test Manufacturer: nal von minden GmbH

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eudamed_udi Salmonella typhi Antigen Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi H. pylori Antigen Rapid Test Manufacturer: Acro Biotech Inc.

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eudamed_udi Brucella IgG/IgM Rapid Test (Serum/Plasma) Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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eudamed_udi Brucella Antibody Test Kit(Serum/plasma/whole blood) Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.

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eudamed_udi Giardia kasetki 20 szt. Manufacturer: BioMaxima Spółka Akcyjna

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eudamed_udi Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi RaeScan+ LYME IgM/IgG Combo Manufacturer: Reagena Oy

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eudamed_udi SIMPLE Strep pneumo-Legio / STICK Strep pneumo-Legio Manufacturer: OPERON, S.A.

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eudamed_udi Mycobacterium Tuberculosis Antibody Rapid Test Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.

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eudamed_udi M. tuberculosis Antigen Rapid Test Manufacturer: Hangzhou Clongene Biotech Co., Ltd.

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eudamed_udi Giardia lamblia Test Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.

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eudamed_udi Tuberculosis (TB) Test Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.

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eudamed_udi Gonorrhea + Chlamydia Antigen Combo Test Cassette Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.

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eudamed_udi Shigella Sonnei Antigen Rapid Test Manufacturer: Acro Biotech Inc.

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eudamed_udi biotical E. Coli O157:H7 Card Manufacturer: BIOTICAL HEALTH S.L.U

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eudamed_udi Rapid V.Cholerae O139 Test Card Manufacturer: MP Biomedicals Germany GmbH

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eudamed_udi Tetanos Quick Stick Manufacturer: Eurobio Scientific

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eudamed_udi Lyme IgG/IgM Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi (NGH) Neisseria Gonorrhoeae Test Manufacturer: Abiores Technology (Beijing) Co.,Ltd.

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eudamed_udi Crypto + Giardia kasetki 20 szt. Manufacturer: BioMaxima Spółka Akcyjna

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eudamed_udi biotical Salmonella typhi Card (+PC) Manufacturer: BIOTICAL HEALTH S.L.U

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eudamed_udi Campylobacter kasetki 20 szt. Manufacturer: BioMaxima Spółka Akcyjna

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eudamed_udi Rickettsia Test Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.

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eudamed_udi biotical Salmonella Card (+PC +NC) Manufacturer: BIOTICAL HEALTH S.L.U

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eudamed_udi Vibrio Cholerae O1/O139 Antigen Rapid Test Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.

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eudamed_udi Cholera O1 Antigen Rapid Test(Feces) Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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eudamed_udi Gonorrhea Test Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

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eudamed_udi Typhoid IgG/IgM Rapid Test Kit (Colloidal gold method) Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.

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eudamed_udi Neisseria Gonorrhoeae Antigen Rapid Test Manufacturer: Avioq Bio-tech Co., Ltd.

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eudamed_udi E.Coli Test Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

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eudamed_udi biotical Salmonella paratyphi Card (+PC +NC) Manufacturer: BIOTICAL HEALTH S.L.U

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eudamed_udi Candida Albicans/Gardnerella Vaginalis /Trichomonas Vaginalis Combo Rapid Test（Swab） Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.

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eudamed_udi Candida Strip Test Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

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eudamed_udi Rapid Rickettsia IgG/IgM Combo Test Card Manufacturer: Xiamen Boson Biotech Co., Ltd.

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eudamed_udi S.pneumoniae/L.pneumoohila Combo Rapid Test Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.

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eudamed_udi biotical Campylobacter Card (+PC +NC) Manufacturer: BIOTICAL HEALTH S.L.U

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eudamed_udi Rapid V. cholerae O1 Test Strip Manufacturer: MP Biomedicals Germany GmbH

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eudamed_udi Salmonella typhi/ Salmonella paratyphi IgG/IgM Antibodies Assay Kit(Colloidal gold) Manufacturer: Avioq Bio-tech Co., Ltd.

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eudamed_udi Treponema pallidum Antibody Test Kit Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD

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eudamed_udi Shigella lgG/lgM Test Kit(Serum/plasma/whole blood) Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.

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eudamed_udi Gonorrhea Test Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

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eudamed_udi Leptospira IgG/IgM Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi CerTest Campylobacter Manufacturer: CERTEST BIOTEC S.L.

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eudamed_udi Cholera O1 Antigen Rapid Test Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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eudamed_udi Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Mycoplasma pneumoniae Antigen Rapid Test Manufacturer: Hangzhou Clongene Biotech Co., Ltd.

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eudamed_udi Rapid Anti-TB (Mycobacterium Tuberculosis) Test Manufacturer: InTec PRODUCTS, INC.

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eudamed_udi Tuberculosis Rapid Test Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.

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eudamed_udi Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Ehrlichia Antibody Rapid Test Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.

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eudamed_udi Leptospira IgG/IgM Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi Campylobacter Rapid Test Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.

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eudamed_udi W0105090199 Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi biotical E. Coli O157:H7 Card (+PC +NC) Manufacturer: BIOTICAL HEALTH S.L.U

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eudamed_udi Gardneralla Vaginalis Rapid Test Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD

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eudamed_udi INDICAID™ Mycoplasma Pneumoniae (MP) Rapid IgM Antibody Test Manufacturer: Phase Scientific International Limited

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eudamed_udi Tuberculosis (TB) Test Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.

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eudamed_udi M.Tuberculosis serum Test Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

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eudamed_udi Salmonella typhi/ Salmonella paratyphi antigens Assay Kit(Colloidal gold) Manufacturer: Avioq Bio-tech Co., Ltd.

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eudamed_udi Tuberculosis (TB) Test Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.

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eudamed_udi Capilia TB-Neo Manufacturer: TAUNS Laboratories, Inc.

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eudamed_udi 20 Tests/Kit Manufacturer: Labnovation Technologies, Inc.

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eudamed_udi SALMONELLA Test Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

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eudamed_udi Scrub Typhus IgG/IgM Rapid Test Cassette Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Simple/Stick Campylobacter Manufacturer: OPERON, S.A.

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eudamed_udi Scrub Typhus IgG/IgM Test Kit(Serum/plasma/whole blood) Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.

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eudamed_udi Vibrio Cholerae O1/O139 Antigen Rapid Test Cassette (Feces) Manufacturer: Hangzhou Clongene Biotech Co., Ltd.

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eudamed_udi Salmonella typhi/ Salmonella paratyphi antigens Assay Kit(Colloidal gold) Manufacturer: Avioq Bio-tech Co., Ltd.

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eudamed_udi Candida Cassette Test Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

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eudamed_udi Vibrio cholerae O1 (VC O1) Rapid Test Cassette Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Vibrio Cholerae O139,O1 Ogawa & Inaba Combo Rapid Test Manufacturer: Acro Biotech Inc.

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eudamed_udi Trichomonus Test Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

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eudamed_udi Gonorrhoea Rapid Test(Swab) Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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eudamed_udi Leptospira IgG/IgM Rapid Test Manufacturer: Hangzhou Clongene Biotech Co., Ltd.

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eudamed_udi TP Syphilis Test Manufacturer: Abiores Technology (Beijing) Co.,Ltd.

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eudamed_udi Tuberculosis Rapid Test Kit(Whole Blood/serum/plasma) Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

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eudamed_udi Immunochromatographic One Step Rapid Visual Test for Vibrio cholerae – Dipstick Manufacturer: ARKRAY Healthcare Pvt. Ltd.

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eudamed_udi Typhoid IgM Rapid Test Cassette Manufacturer: Acro Biotech Inc.

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eudamed_udi Tetanos Quick Stick Manufacturer: Eurobio Scientific

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eudamed_udi Salmonella typhi Antigen Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi B-IBP-ACO502VN Manufacturer: Acro Biotech Inc.

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eudamed_udi Rapid Salmonella typhi/paratyphi Antigen Duo Test Manufacturer: Xiamen Boson Biotech Co., Ltd.

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eudamed_udi Vibrio Cholerae O1 Antigen Rapid Test Manufacturer: GeneSign Biotech (Xiamen)Co., Ltd.

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eudamed_udi Typhoid Rapid Test Kit（Colloidal Gold） Manufacturer: BIOBASE POCT CO.,LTD

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eudamed_udi M.Tuberculosis serum Test Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

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eudamed_udi Accu-Tell® Typhoid Cassette Manufacturer: AccuBioTech Co., Ltd.

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eudamed_udi Salmonella typhi Antigen Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Salmonella typhi Antigen Rapid Test Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.

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eudamed_udi Shigella Sonnei Antigen Rapid Test Cassette Manufacturer: Acro Biotech Inc.

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FDA Product Code: W0105090199