General Biologicals · 89-08 · TAIWAN
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
- 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
- Hsinchu Science Park, Baoshan Township , No 6 Innovation First Rd , Hsinchu Tai, TAIWAN verified
- Date published
- 01/22/2016 verified
- 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 each item verified
- 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 each item verified
- FDA notes
- Problem; Class III Device verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html