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Results for “Chemiluminescent Immunoassay Assay Kits for Total Prostate Specific Antigen (f-PSA)”

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Registry EUDAMED 12 FDA 510(k) incl. De Novo FDA PMA GUDID

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Class A Class B Class C Class D IVD General IVD Annex II List A IVD Annex II List B 12 IVD for self-testing Active implantable (AIMDD) Unclassified (FDA) Not classified (FDA)

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Chemiluminescent Immunoassay Assay Kits for Total Prostate Specific Antigen (f-PSA)

Maccura Biotechnology Co., Ltd.,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List B
Chemiluminescent Immunoassay Assay Kits for Free Prostate Specific Antigen (t-PSA)

Maccura Biotechnology Co., Ltd.,China Group of variants

Active Regimes: CE IVDD Registry: EUDAMED Class:IVD Annex II List B

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