Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007652384

FEI Number

3007652384

Entity Name

MICROBIX

City/State/Country

Mississauga Ontario, CA

Establishment Address

265 Watline Avenue, Mississauga Ontario L4Z 1P3, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Microbix (Owner Number: 10061165)

Owner / Operator Contact Address

265 Watline Avenue, Mississauga, CA-ON L4Z 1P3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2019-09-03

Official Correspondent

Bo Hollas

US Agent Details

Jamie Harris Business: Icon Clinical Research Email: jamie.harris@iconplc.com Phone: (661) 6459048

Related Public Records

Same Entity

Microbix

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007652384. Last updated year: 2026. Please use registration number 3007652384 when referencing this establishment in official correspondence.