PROPRIETARY INNOVATION LABS INC. · 89-08 · CANADA
For PROPRIETARY INNOVATION LABS INC. · 89-08 · CANADA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CANADA; product is COVID-19 IgM/IgG test kit (Colloidal Gold) | Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold) | Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold) | COVID-19 IgM/IgG test kit (Colloidal Gold) | COVID-19 IgM/IgG test kit (Colloidal Gold); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/17/2020; address is 345 Wilson Ave Suite 306 , North York, Ontario CANADA, verified against its source on 2026-09-16.
- Firm
- PROPRIETARY INNOVATION LABS INC. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CANADA verified
- Address
- 345 Wilson Ave Suite 306 , North York, Ontario CANADA verified
- Date published
- 07/17/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- COVID-19 IgM/IgG test kit (Colloidal Gold) | Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold) | Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold) | COVID-19 IgM/IgG test kit (Colloidal Gold) | COVID-19 IgM/IgG test kit (Colloidal Gold) each item verified
What the source says
PROPRIETARY INNOVATION LABS INC. Date Published : 07/17/2020 345 Wilson Ave Suite 306 , North York, Ontario CANADA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/17/2020 Desc: COVID-19 IgM/IgG test kit (Colloidal Gold) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/17/2020 Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 07/17/2020 Desc: Helix-19 COVID-19 IgM/IgG Test Kit (Colloidal Gold) 83 Q - - KO Reagent, coronavirus serological Date Published: 07/17/2020 Desc: COVID-19 IgM/IgG test kit (Colloidal Gold) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/17/2020 Desc: COVID-19 IgM/IgG test kit (Colloidal Gold)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html