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Registry EUDAMED FDA 510(k) 39 FDA PMA 1 GUDID

Country / market United States 40

Risk class Class I Class IIa Class IIb Class III 1 Class II (US) 39

More classes (11)

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

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40 devices foundsorted by relevance

Manufacturer: Centers For Disease Control And Prevention× Clear all

Device · Manufacturer · Authorizations

Francisella tularensis Real-time PCR assay

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active 510(k) 510(k) II
2 variants
- Francisella tularensis Real-time PCR Assay K260812
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active 510(k) 510(k) II
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active 510(k) 510(k) II
5 variants
- Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set K181205
- See all variants of this device
Cdc Human Influenza Virus Real-Time Rt-Pcr Diagnostic Panel

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active 510(k) 510(k) II
4 variants
Cdc Human Influenza Virus Real-Time Rt- Pcr Detection And Characterization Panel

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active 510(k) 510(k) II
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active CE IVDD 510(k) 510(k) II
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active 510(k) 510(k) II
Synthetic Vdrl Antigen

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active 510(k) 510(k) II
Influenza A Subtyping Kit, Cdc Human Influenza Virus Real-Time Rt-Pcr Diagnostic Panel

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active 510(k) 510(k) II
Influenza A/H5 (Asian Lineage) Virus Real-Time Rt-Pcr Primer And Probe Set

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active De Novo 510(k) II
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

Centers For Disease Control and Prevention (CDC),FDA registration: United States Class II

Active 510(k) 510(k) II
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active 510(k) 510(k) II
Variola virus Real-Time PCR Assay

Centers For Disease Control and Prevention (CDC),FDA registration: United States Class II

Active De Novo 510(k) II
Cdc Influenza 2009 A(H1N1)Pdm Real-Time Rt-Pcr Panel

Centers For Disease Control And Prevention,FDA registration: United States Class II

Active 510(k) 510(k) II
Afp Mid-Pregnancy Reference Preparation

Centers For Disease Control And Prevention,FDA registration: United States Class III

Withdrawn PMA, withdrawn PMA III

Showing 21-40 of 40

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