FDA Registration
Active
🇨🇦 Canada
MICROBIX
Reg #: 3007652384
·
FEI: 3007652384
·
Expires 2026
Products
1
Proprietary Names
156
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MICROBIX
- Registration Number
- 3007652384
- FEI Number
- 3007652384
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 265 Watline Avenue
- City
- Mississauga Ontario
- Country
- CA
Owner / Operator
- Firm Name
- Microbix
- Operator Number
- 10061165
- Address
- 265 Watline Avenue
- City
- Mississauga
- State
- Ontario
- Postal Code
- L4Z 1P3
- Country
- CA
- Correspondent
- Bo Hollas
US Agent
- Business Name
- Icon Clinical Research
- Contact Name
- Jamie Harris
- Address
- 731 Arbor Way Ste 100
- City
- Blue Bell
- State
- PA
- ZIP
- 19422
- Country
- US
- [email protected]
- Phone
- 661 6459048
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2019-09-03 |
Proprietary Names
REDx Clostridium difficile Positive Control
REDxFLOQ® Clostridium difficile Swab Positive Control
REDx Shigella sonnei Positive Control
REDx Cryptosporidium parvum Positive Control (MDx)
REDxFLOQ® Norovirus GI Ag Swab Positive Control
REDxFLOQ® Norovirus GII Ag Swab Positive Control
REDxFLOQ® Plesiomonas shigelloides Swab Positive Control
REDxFLOQ® Norovirus GII Swab Positive Control
REDxFLOQ® HPV 31/33/66 Swab Positive Control
REDx Norovirus GI Positive Control
REDxFLOQ® HPV Swab Negative Control
REDxFLOQ® HSV2 and VZV Swab Positive Control
REDxFLOQ® Enteric Parasite Panel Swab Positive Control
REDxFLOQ® HSV1 and HSV2 Swab Positive Control
REDxFLOQ® Trichomonas vaginalis & Mycoplasma genitalium Swab Positive Control
REDxFLOQ® Vibrio parahaemolyticus Swab Positive Control
REDxFLOQ® Adenovirus F40/41 Swab Positive Control
REDx Giardia lamblia Positive Control (MDx)
REDxFLOQ® HPV 45 Swab Positive Control
REDxFLOQ® HSV1 Swab Positive Control
REDxFLOQ® Human Metapneumovirus Swab Positive Control
REDxFLOQ® Norovirus GI Swab Positive Control
REDxFLOQ® Enteric Viral Panel Swab Positive Control
REDxFLOQ® HPV 31/33/39 Swab Positive Control (Normalized Viral Load)
REDxFLOQ® CT/NG/TV/MG Swab Positive Control
REDx Enteric Bacterial Panel 2 Positive Control
EDxFLOQ® Entamoeba histolytica Swab Positive Control
REDxFLOQ® Sapovirus Swab Positive Control
REDx Enteric Parasite Panel Positive Control
REDxFLOQ® HSV1 and VZV Swab Positive Control
REDxFLOQ® Neisseria gonorrhoeae Swab Positive Control
REDx Sapovirus Positive Control
REDxFLOQ® Trichomonas vaginalis Swab Positive Control
REDxFLOQ® Treponema pallidum Swab Positive Control
REDxFLOQ® VZV Swab Positive Control
REDx Plesiomonas shigelloides Positive Control
REDxFLOQ® Enteric Bacterial Panel 2 Swab Positive Control
REDxFLOQ® Cryptosporidium parvum Swab Positive Control (MDx)
REDxFLOQ® Astrovirus Swab Positive Control
REDxFLOQ® Seasonal Coronavirus NL63 Swab Positive Control
REDx Seasonal Coronavirus NL63 Positive Control
REDxFLOQ® Respiratory Viral Panel 1 Swab Positive Control
REDx Enterovirus Positive Control
REDx Respiratory Viral Panel 1 Positive Control
REDxFLOQ® M. genitalium A2059G Swab Positive Control
REDx HPV 52 Positive Control
REDx SARS-CoV-2 Negative Control
REDxFLOQ® SARS-CoV-2 B.1.1.529 Swab Positive Control
REDxFLOQ® Respiratory Swab Negative Control
REDxFLOQ® M. genitalium A2058G Swab Positive Control
REDx Cryptosporidium parvum Positive Control
REDx Trichomonas vaginalis Positive Control
REDxFLOQ® Respiratory NAAT Influenza A Swab Positive Control
REDxFLOQ® Influenza B Swab Positive Control
REDx STI Negative Control
REDxFLOQ® M. genitalium A2058C Swab Positive Control
REDx SARS-CoV-2 Positive Control
REDx FLOQ® RSV Swab Positive Control
REDx FLOQ® SARS-CoV-2 Swab Negative Control
REDxFLOQ® Respiratory NAAT Influenza A and RSV Swab Positive Control
REDxFLOQ® Respiratory NAAT RSV Swab Positive Control (Low Level)
REDx hr-HPV Negative Control
REDx Chlamydia trachomatis and Neisseria gonorrhoeae Positive Control
REDxFLOQ® HSV1&2/VZV/T. pallidum Swab Positive Control
REDx Cryptosporidium parvum and Giardia lamblia Positive Control
REDx Neisseria gonorrhoeae Positive Control
REDxFLOQ® SARS-CoV-2 Ag Swab Positive Control
REDx HPV 18 Positive Control
REDxFLOQ® Respiratory NAAT Influenza A and SARS-CoV-2 Swab Positive Control
REDx HPV 31/33/66 Positive Control
REDxFLOQ® Respiratory NAAT RSV Swab Positive Control
REDx HPV 16 Positive Control
REDx HPV 51 Positive Control
REDx Influenza A Positive Control
REDxFLOQ® Influenza A Swab Positive Control
REDxFLOQ® Respiratory NAAT RSV and SARS-CoV-2 Swab Positive Control
REDxFLOQ® Respiratory NAAT Influenza B Swab Positive Control (Low Level)
REDx Influenza B Positive Control
REDxFLOQ® Respiratory NAAT Influenza A Swab Positive Control (Low Level)
REDxFLOQ® Group A Streptococcus Swab Positive Control
REDx Chlamydia trachomatis Positive Control
REDxFLOQ® CT/NG/TV Swab Positive Control
REDxFLOQ® M. genitalium A2058T Swab Positive Control
REDx HPV 39 Positive Control
REDxFLOQ® SARS-CoV-2/Flu A&B/ RSV Swab Positive Control
REDx Influenza A and Influenza B Positive Control
REDxFLOQ® M. genitalium A2059C Swab Positive Control
REDx Salmonella enteritidis Positive Control
REDx HPV 31 Positive Control
REDxFLOQ® HPV 16/18/45 Swab Positive Control
REDx MG Positive Control
REDxFLOQ® HPV 18 Swab Positive Control
REDx Shiga toxin-producing E. coli Positive Control
REDx HPV 39/51/52 Positive Control
REDxFLOQ® SARS-CoV-2 B.1.617 Swab Positive Control
REDxFLOQ® Monkeypox West African Swab Positive Control
REDx Rotavirus Positive Control
REDxFLOQ® Respiratory NAAT Influenza B and SARS-CoV-2 Swab Positive Control
REDxFLOQ® T. pallidum and VZV Swab Positive Control
REDxFLOQ® Respiratory NAAT Influenza A and Influenza B Swab Positive Control
REDxFLOQ® SARS-CoV-2 B.1.351 Swab Positive Control
REDx Enterotoxigenic E. coli Positive Control
REDxFLOQ® SARS-CoV-2 Swab Positive Control
REDx HPV 16/18/45 Positive Control
REDx HPV 66 Positive Control
REDxFLOQ® Respiratory NAAT Influenza B Swab Positive Control
REDxFLOQ® Giardia lamblia Swab Positive Control (MDx)
REDx Campylobacter jejuni Positive Control
REDxFLOQ® HSV1/HSV2/VZV Swab Positive Control
REDxFLOQ® Chlamydia trachomatis Swab Positive Control
REDxFLOQ® Respiratory NAAT Influenza B and RSV Swab Positive Control
REDx HPV 45 Positive Control
REDx Giardia lamblia Positive Control
REDxFLOQ® SARS-CoV-2 B.1.1.7 Swab Positive Control
REDxFLOQ® Mycoplasma genitalium Swab Positive Control
REDx Norovirus GII Positive Control
REDxFLOQ® Enterotoxigenic E. coli Swab Positive Control
REDxFLOQ® Chlamydia trachomatis & Neisseria gonorrhoeae Swab Positive Control
REDxFLOQ® HSV2 Swab Positive Control
REDxFLOQ® HSV2 and T. pallidum Swab Positive Control
REDx CT/NG/MG FQr & MLr Positive Control
REDx Chlamydia trachomatis Positive Control (MDx)
REDx HPV 33 Positive Control
REDxFLOQ® Yersinia enterocolitica Swab Positive Control
REDx Vibrio parahaemolyticus Positive Control
REDxFLOQ® Group A Streptococcus Swab Positive Control (M2)
REDx TV/NG FQr/MG MLr Positive Control
REDxFLOQ® HPV 18 Swab Positive Control (Normalized Viral Load)
REDx Adenovirus F40/41 Positive Control
REDxFLOQ® HPV 45 Swab Positive Control (Normalized Viral Load)
REDxFLOQ® Enteric Bacterial Panel 1 Swab Positive Control
REDx Yersinia enterocolitica Positive Control
REDxFLOQ® SARS-CoV-2 P.1 Swab Positive Control
REDx HSV2 Positive Control
REDx Rotavirus Positive Control (MDx)
REDxFLOQ® HPV 16 Swab Positive Control (Normalized Viral Load)
REDxFLOQ® Shigella sonnei Swab Positive Control
REDx RSV Positive Control
REDxFLOQ® Salmonella enteritidis Swab Positive Control
REDx HSV1 Positive Control
REDxFLOQ® Rotavirus Swab Positive Control (MDx)
REDx Entamoeba histolytica Positive Control
REDx Enteric Viral Panel Positive Control
REDx Rhinovirus Positive Control
REDx Astrovirus Positive Control
REDxFLOQ® Group A Streptococcus Swab Positive Control (M1)
REDxFLOQ® HPV 39/51/52 Swab Positive Control
REDxFLOQ® Shiga toxin-producing E. coli Swab Positive Control
REDxFLOQ® Enterovirus Swab Positive Control
REDx Human Metapneumovirus Positive Control
REDxFLOQ® Rhinovirus Swab Positive Control
REDxFLOQ® H. pylori Swab Positive Control
REDxFLOQ® HPV 16 Swab Positive Control
REDxFLOQ® Campylobacter jejuni Swab Positive Control
REDxFLOQ® HSV1 and T. pallidum Swab Positive Control
REDx Enteric Bacterial Panel 1 Positive Control
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device