# General Biologicals · 89-08 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

For General Biologicals · 89-08 · TAIWAN, 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 TAIWAN; product is EASE BN-96 | GB SARS-CoV-2 Real-Time RT-PCR | GB SARS-CoV-2 Ab ELISA | GB SARS-CoV-2 Real-Time RT-PCR; product code is 83 L - - OM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 88 P - - PM General purpose reagent; date published is 01/22/2016; address is Hsinchu Science Park, Baoshan Township , No 6 Innovation First Rd , Hsinchu Tai, TAIWAN, verified against its source on 2026-09-16.

- **Firm:** General Biologicals _(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:** TAIWAN _(verified: appears in the quote below)_
- **Address:** Hsinchu Science Park, Baoshan Township , No 6 Innovation First Rd , Hsinchu Tai, TAIWAN _(verified: appears in the quote below)_
- **Date published:** 01/22/2016 _(verified: appears in the quote below)_
- **Product code:** 83 L - - OM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 88 P - - PM General purpose reagent _(verified: each item appears in the quote below)_
- **Product:** EASE BN-96 | GB SARS-CoV-2 Real-Time RT-PCR | GB SARS-CoV-2 Ab ELISA | GB SARS-CoV-2 Real-Time RT-PCR _(verified: each item appears in the quote below)_
- **FDA notes:** Problem; Class III Device _(verified: appears in the quote below)_

## What the source says

> General Biologicals Date Published : 01/22/2016 Hsinchu Science Park, Baoshan Township , No 6 Innovation First Rd , Hsinchu Tai, TAIWAN 83 L - - OM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Date Published: 01/22/2016 Desc: EASE BN-96 Notes: Problem; Class III Device 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/13/2022 Desc: GB SARS-CoV-2 Real-Time RT-PCR 83 Q - - KO Reagent, coronavirus serological Date Published: 06/16/2021 Desc: GB SARS-CoV-2 Ab ELISA 88 P - - PM General purpose reagent Date Published: 06/13/2022 Desc: GB SARS-CoV-2 Real-Time RT-PCR

## 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/).