FDA Registration
Active
🇨🇦 Canada
REDxFLOQ® Campylobacter jejuni Swab Positive Control
Reg #: 3007652384
·
FEI: 3007652384
·
Expires 2025
Products
1
Proprietary Names
83
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MICROBIX
- Registration Number
- 3007652384
- FEI Number
- 3007652384
- Status
- Active
- Expiry Year
- 2025
- 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
REDxFLOQ® Campylobacter jejuni Swab Positive Control
REDx Shiga toxin-producing E. coli Positive Control
REDxFLOQ® HPV 45 Swab Positive Control
REDxFLOQ® HPV 18 Swab Positive Control
REDxFLOQ® Salmonella enteritidis Swab Positive Control
REDxFLOQ® HPV 16/18/45 Swab Positive Control
REDxFLOQ® HPV 16 Swab Positive Control
REDx Enteric Bacterial Panel 1 Positive Control
REDx Shigella sonnei Positive Control
REDxFLOQ® Shigella sonnei Swab Positive Control
REDxFLOQ® Clostridium difficile Swab Positive Control
REDx SARS-CoV-2 Negative Control
REDxFLOQ® SARS-CoV-2 Ag Swab Positive Control
REDx HPV 66 Positive Control
REDx HPV 39 Positive Control
REDxFLOQ® M. genitalium A2058T Swab Positive Control
REDxFLOQ® Respiratory Swab Negative Control
REDxFLOQ® HSV1&2/VZV/T. pallidum Swab Positive Control
REDxFLOQ® M. genitalium A2059G Swab Positive Control
REDxFLOQ® SARS-CoV-2 B.1.1.7 Swab Positive Control
REDx HPV 33 Positive Control
REDx Influenza B Positive Control
REDx RSV Positive Control
REDx HPV 52 Positive Control
REDxFLOQ® SARS-CoV-2 B.1.1.529 Swab Positive Control
REDxFLOQ® SARS-CoV-2 B.1.617 Swab Positive Control
REDxFLOQ® CT/NG/TV Swab Positive Control
REDxFLOQ® Respiratory NAAT RSV and SARS-CoV-2 Swab Positive Control
REDxFLOQ® Group A Streptococcus Swab Positive Control
REDxFLOQ® Influenza A Swab Positive Control
REDx Giardia lamblia Positive Control
REDx Cryptosporidium parvum and Giardia lamblia Positive Control
REDx HPV 31/33/66 Positive Control
REDxFLOQ® Group A Streptococcus Swab Positive Control (M1)
REDxFLOQ® Respiratory NAAT Influenza A Swab Positive Control
REDxFLOQ® Respiratory NAAT Influenza B and RSV Swab Positive Control
REDxFLOQ® M. genitalium A2058G Swab Positive Control
REDx HPV 16/18/45 Positive Control
REDx HPV 51 Positive Control
REDx hr-HPV Negative Control
REDx HPV 39/51/52 Positive Control
REDxFLOQ® SARS-CoV-2 P.1 Swab Positive Control
REDxFLOQ® Respiratory NAAT Influenza A and RSV Swab Positive Control
REDx FLOQ® SARS-CoV-2 Swab Negative Control
REDx HSV2 Positive Control
REDxFLOQ® Respiratory NAAT RSV Swab Positive Control (Low Level)
REDxFLOQ® Respiratory NAAT RSV Swab Positive Control
REDxFLOQ® Influenza B Swab Positive Control
REDx Influenza A and Influenza B Positive Control
REDxFLOQ® Respiratory NAAT Influenza A and SARS-CoV-2 Swab Positive Control
REDxFLOQ® Respiratory NAAT Influenza B Swab Positive Control (Low Level)
REDxFLOQ® Group A Streptococcus Swab Positive Control (M2)
REDxFLOQ® Respiratory NAAT Influenza A Swab Positive Control (Low Level)
REDxFLOQ® Respiratory NAAT Influenza B Swab Positive Control
REDx HPV 18 Positive Control
REDx MG Positive Control
REDx HPV 45 Positive Control
REDx Trichomonas vaginalis Positive Control
REDxFLOQ® SARS-CoV-2 Swab Positive Control
REDx Chlamydia trachomatis Positive Control (MDx)
REDx HSV1 Positive Control
REDxFLOQ® M. genitalium A2058C Swab Positive Control
REDx HPV 31 Positive Control
REDx STI Negative Control
REDx FLOQ® RSV Swab Positive Control
REDx HPV 16 Positive Control
REDx SARS-CoV-2 Positive Control
REDxFLOQ® SARS-CoV-2/Flu A&B/ RSV Swab Positive Control
REDxFLOQ® M. genitalium A2059C Swab Positive Control
REDxFLOQ® SARS-CoV-2 B.1.351 Swab Positive Control
REDx Chlamydia trachomatis Positive Control
REDx Neisseria gonorrhoeae Positive Control
REDx Rotavirus Positive Control
REDxFLOQ® Respiratory NAAT Influenza A and Influenza B Swab Positive Control
REDx Influenza A Positive Control
REDx Cryptosporidium parvum Positive Control
REDxFLOQ® Enteric Bacterial Panel 1 Swab Positive Control
REDx Salmonella enteritidis Positive Control
REDx Campylobacter jejuni Positive Control
REDx Chlamydia trachomatis and Neisseria gonorrhoeae Positive Control
REDx Clostridium difficile Positive Control
REDxFLOQ® Respiratory NAAT Influenza B and SARS-CoV-2 Swab Positive Control
REDxFLOQ® Shiga toxin-producing E. coli Swab Positive Control
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device