BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel

FDA UDI

BIOFIRE DIAGNOSTICS, LLC·00815381020659·IVD reagent kit containing 30 tests.

RapidFor™ SARS-CoV-2 + Flu A/B + RSV + hMPV Combo Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

SARS-CoV-2, Respiratory Syncytium, and Influenza A&B Antigen Combined Detection Kit(Latex Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device

Influenza A/Influenza B/SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence PCR Method)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Suzhou TianLong Biotechnology Co., Ltd.·1 device

ZENA MAX Respiratory Panel 4 SARS-CoV-2 and Coronavirus (HKU1, NL63, OC43, 229E)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Advanced Molecular Diagnostics Ltd·1 device

SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device

Novel Coronavirus (SARS-CoV-2) and Influenza A/B Virus RT-qPCR Detection Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Nanjing Vazyme Medical Technology Co.,Ltd.·1 device

Freeze-dried Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2 -Subpackage

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device

Novel Coronavirus (SARS-CoV-2) Real-Time Multiplex RT-PCR Kit (RR-0487-02)

Basic UDI-DI

EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·1 device

Novel Coronavirus (SARS-CoV-2) Real-Time Multiplex RT-PCR Kit (RR-0487-02)

Basic UDI-DI

EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·1 device

Novel Coronavirus (SARS-CoV-2) Real-Time Multiplex RT-PCR Kit (RR-0485-02)

Basic UDI-DI

EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·1 device

SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) Saliva Test

Basic UDI-DI

EU IVDD · Eu Ivd General ·Nanjing Synthgene Medical Technology Co., Ltd. ·1 device

Schweres akutes Atemwegssyndrom-Coronavirus-Typ 2 (SARS-CoV-2) Antigennachweis-Kit, kollodial, auf Goldbasis

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Maccura Biotechnology Co., Ltd. ·1 device

Schweres akutes Atemwegssyndrom-Coronavirus-Typ 2 (SARS-CoV-2) Antigennachweis-Kit, kollodial, auf Goldbasis

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Maccura Biotechnology Co., Ltd. ·1 device

Schweres akutes Atemwegssyndrom-Coronavirus-Typ 2 (SARS-CoV-2) Antigennachweis-Kit, kollodial, auf Goldbasis

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Maccura Biotechnology Co., Ltd. ·1 device

Schweres akutes Atemwegssyndrom-Coronavirus-Typ 2 (SARS-CoV-2) Antigennachweis-Kit, kollodial, auf Goldbasis

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Maccura Biotechnology Co., Ltd. ·1 device

Covid-19 Multi-Analyte Antigen Device

FDA classification

FDA Not Classified ·Covid-19 Multi-Analyte Antigen Device

Multiple Rapid Real-Time PCR kit for Detection of SARS-CoV-2 (Fluorescent PCR Method）

Basic UDI-DI

EU IVDD · Eu Ivd General ·Nantong EgensBiotechnology Co.,Ltd.·1 device

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (Isothermal Amplification)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device