General Biologicals · 89-08 · TAIWAN

For General Biologicals, 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 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 2026-09-30.

What the source says

General Biologicals Date Published : 01/22/2016 Hsinchu Science Park, Baoshan Township , No 6 Innovation First Rd , Hsinchu Tai, 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.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.