# AccoBiotech · 89-08 · MALAYSIA — FDA import alert red lists: firms subject to detention without physical examination

For AccoBiotech · 89-08 · MALAYSIA, 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 MALAYSIA; product is ACCO COVID-19 IgM/IgG TEST | ACCO COVID-19 IgM/IgG TEST | ACCO COVID-19 IgM/IgG TEST; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2020; address is Bandar Seri Alam, 81750 , No. 11 Jalan Bukit 27, Masai , Masai, Johor MALAYSIA, verified against its source on 2026-09-16.

- **Firm:** AccoBiotech _(verified: appears in the quote below)_
- **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:** MALAYSIA _(verified: appears in the quote below)_
- **Address:** Bandar Seri Alam, 81750 , No. 11 Jalan Bukit 27, Masai , Masai, Johor MALAYSIA _(verified: appears in the quote below)_
- **Date published:** 06/22/2020 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** ACCO COVID-19 IgM/IgG TEST | ACCO COVID-19 IgM/IgG TEST | ACCO COVID-19 IgM/IgG TEST _(verified: each item appears in the quote below)_

## What the source says

> AccoBiotech Date Published : 06/22/2020 Bandar Seri Alam, 81750 , No. 11 Jalan Bukit 27, Masai , Masai, Johor MALAYSIA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: ACCO COVID-19 IgM/IgG TEST 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: ACCO COVID-19 IgM/IgG TEST 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: ACCO COVID-19 IgM/IgG TEST

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).