Microbix Biosystems Inc.

Canada CA-MF-000028149 Last updated 21 Oct 2026

Devices: 18
Registries: EUDAMEDFDA 510(k)
FDA recalls: 0

Catalogue18

REDxFLOQ Respiratory Swab Negative Control Ref RED-S-99-01

Class B EUDAMED Active
Mycoplasma Spp Serological Reagents Ref K852933

Class I FDA 510(k) Active
Herpes Hominus I-Comple Fix Antigen & Negative Clt Ref K852931

Class II FDA 510(k) Active
Toxoplasma Gondii-Cf Antigen And Control Antigen Ref K894261

Class II FDA 510(k) Active
Measles-Complement Fix Antigen & Negative Clt Ref K852932

Class I FDA 510(k) Active
Cmv-Complement Fixation Antigen And Negative Contr Ref K852929

Class II FDA 510(k) Active
Rubella Antigen And Control Antigen Ref K894262

Class II FDA 510(k) Active
Varicella-Zoster-Comple Fix Antigen And Neg Contro Ref K852930

Class II FDA 510(k) Active
REDx HPV 45 Positive Control Ref RED-62-45

Class B EUDAMED Active
REDx SARS-CoV-2 Positive Control Ref RED-19-01

Class B EUDAMED Active
REDx Mycoplasma genitalium Positive Control Ref RED-63-01

Class B EUDAMED Active
REDx STI Negative Ref RED-99-M1

Class B EUDAMED Active
REDx HPV 16 Positive Control Ref RED-62-16

Class B EUDAMED Active
REDxFLOQ SARS-CoV-2 Ag Swab Positive Control Ref RED-S-19-02

Class B EUDAMED Active
REDxFLOQ SARS-CoV-2 Swab Positive Control Ref RED-S-19-01

Class B EUDAMED Active
REDx SARS-CoV-2 Negative Control Ref RED-99-M3

Class B EUDAMED Active
REDx HPV 18 Positive Control Ref RED-62-18

Class B EUDAMED Active
REDxFLOQ SARS-CoV-2 Swab Negative Control Ref RED-S-99-M4

Class B EUDAMED Active

Authorised representatives

Obelis s.a. BE

About

We offer cutting-edge biological and technical infectious disease diagnostic solutions and vial filling solutions for the global diagnostics industry.

From the manufacturer's own website. Source

Information

Country: Canada
Address: 265, Watline Avenue, Mississauga, Ontario, Canada
Website: www.microbix.com
LinkedIn: linkedin.com/company/microbix
Facebook: facebook.com/MicrobixBiosystems
Email: [email protected]
Phone: +18007946694(from company website)
PRRC contact: Bo Hollas
EUDAMED SRN: CA-MF-000028149

Catalogue18

REDxFLOQ Respiratory Swab Negative Control Ref RED-S-99-01

Mycoplasma Spp Serological Reagents Ref K852933

Herpes Hominus I-Comple Fix Antigen & Negative Clt Ref K852931

Toxoplasma Gondii-Cf Antigen And Control Antigen Ref K894261

Measles-Complement Fix Antigen & Negative Clt Ref K852932

Cmv-Complement Fixation Antigen And Negative Contr Ref K852929

Rubella Antigen And Control Antigen Ref K894262

Varicella-Zoster-Comple Fix Antigen And Neg Contro Ref K852930

REDx HPV 45 Positive Control Ref RED-62-45

REDx SARS-CoV-2 Positive Control Ref RED-19-01

REDx Mycoplasma genitalium Positive Control Ref RED-63-01

REDx STI Negative Ref RED-99-M1

REDx HPV 16 Positive Control Ref RED-62-16

REDxFLOQ SARS-CoV-2 Ag Swab Positive Control Ref RED-S-19-02

REDxFLOQ SARS-CoV-2 Swab Positive Control Ref RED-S-19-01

REDx SARS-CoV-2 Negative Control Ref RED-99-M3

REDx HPV 18 Positive Control Ref RED-62-18

REDxFLOQ SARS-CoV-2 Swab Negative Control Ref RED-S-99-M4

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