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Results for “Influenza A+B Antigen Test Kit (Colloidal Gold)”

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Registry EUDAMED 63 FDA 510(k) incl. De Novo FDA PMA GUDID

Country / market European Union (all) 63

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Germany 28 Austria 18 Poland 9 Italy 4 Spain 2 France 1 Netherlands 1

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Class A Class B Class C 21 Class D IVD General 40 IVD Annex II List A IVD Annex II List B IVD for self-testing 2 Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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63 devices foundsorted by relevance

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Influenza A+B Antigen Test Kit (Colloidal Gold)

Anhui Deepblue Medical Technology Co., Ltd,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
SARS-CoV-2 & Influenza A+B & RSV&ADV Antigen Combo Test Kit (Colloidal Gold)

Anhui Deepblue Medical Technology Co., Ltd,China

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)

Shenzhen Microprofit Biotech Co., Ltd,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:C
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)

Shenzhen Microprofit Biotech Co., Ltd,China

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold)

Wuhan Life Origin Biotech Joint Stock Co., Ltd.,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
SARS-CoV-2/RhV/PIV & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)

Shenzhen Microprofit Biotech Co., Ltd,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
CESONO：Influenza A+B & COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)

Anhui Deepblue Medical Technology Co., Ltd,China

Active Regimes: CE IVDR Registry: EUDAMED Class:C
Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold)

Wuhan Life Origin Biotech Joint Stock Co., Ltd.,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

Anhui Deepblue Medical Technology Co., Ltd,China Group of variants

Active Regimes: CE IVDR Registry: EUDAMED Class:C
Influenza A+B & RSV Antigen Test Kit (Colloidal Gold)

Anhui Deepblue Medical Technology Co., Ltd,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General
SARS-CoV-2 & Influenza A+B & RSV & ADV & Mycoplasma Pneumoniae Antigen Combo Test Kit (Colloidal Gold)

Anhui Deepblue Medical Technology Co., Ltd,China

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

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