Inno Health Technology, Inc. · 89-08 · TAIWAN
For Inno Health Technology, Inc., import alert is 89-08; country is TAIWAN; 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)"; product is Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) | Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method); product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 03/02/2021; address is 8f-2, No. 61, Section 2 , Kung Yi Road , Taichung, Taiwan, TAIWAN, verified against its source on 2026-09-30.
- Firm
- Inno Health Technology, 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
- TAIWAN verified
- Address
- 8f-2, No. 61, Section 2 , Kung Yi Road , Taichung, Taiwan, TAIWAN verified
- Date published
- 03/02/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) | Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) each item verified
What the source says
Inno Health Technology, Inc. Date Published : 03/02/2021 8f-2, No. 61, Section 2 , Kung Yi Road , Taichung, Taiwan, TAIWAN
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
83 Q - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 03/02/2021 Desc: Aculife COVID19 IgG & IgM Antibody Detection Kit (Colloidal Gold Method)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html