REDx SARS-CoV-2 Negative Control

Device Name

REDx SARS-CoV-2 Positive Control

Model / Reference

RED-19-01, RED-99-M3

Primary DI / UDI-DI

07540224000286

Basic UDI-DI

754022464748BP

EMDN Code

W0105080808 All infectious diseases controls - nat

Device Class

Class B

Market of Registration

Germany

EUDAMED SRN

CA-MF-000028149

Authorised representative

Obelis s.a. BE-AR-000000106

• REDxFLOQ Respiratory Swab Negative Control

  Class B

  CE/IVDR

• Mycoplasma Spp Serological Reagents

  Class I

  FDA 510(k) K852933 Active Cleared 1 Aug 1985

• Herpes Hominus I-Comple Fix Antigen & Negative Clt

  Class II

  FDA 510(k) K852931 Active Cleared 12 Nov 1985

• Toxoplasma Gondii-CF Antigen and Control Antigen

  Class II

  FDA 510(k) K894261 Active Cleared 16 Oct 1989

• Measles-Complement Fix Antigen & Negative Clt

  Class I

  FDA 510(k) K852932 Active Cleared 12 Nov 1985

• Cmv-Complement Fixation Antigen and Negative Contr

  Class II

  FDA 510(k) K852929 Active Cleared 12 Nov 1985

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