# Standard Diagnostics, Inc · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Standard Diagnostics, Inc · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit; product code is 57 V - - 11 Human Immunodeficiency Virus Type 1 | 57 V - - 13 Human Immunodeficiency Virus Type 2 | 57 V - - 14 Human Immunodeficiency Virus Types 1 & 2 | 81 M - - TK Kit, Sample Collection, HIV | 81 M - - TL Monitor, Test, HIV-1 | 81 M - - VZ System, Test, Home, HIV-1 | 82 M - - ZF Test, HIV Detection | 82 N - - HS Assay, Genotype, HIV Drug Resistance, In Vitro; date published is 05/17/2012; address is 156-68 Hagai-Ri, Giheung-Eup, Yongin-Ei , Kyonggi-Do, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Standard Diagnostics, Inc _(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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 156-68 Hagai-Ri, Giheung-Eup, Yongin-Ei , Kyonggi-Do, KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 05/17/2012 _(verified: appears in the quote below)_
- **Product code:** 57 V - - 11 Human Immunodeficiency Virus Type 1 | 57 V - - 13 Human Immunodeficiency Virus Type 2 | 57 V - - 14 Human Immunodeficiency Virus Types 1 & 2 | 81 M - - TK Kit, Sample Collection, HIV | 81 M - - TL Monitor, Test, HIV-1 | 81 M - - VZ System, Test, Home, HIV-1 | 82 M - - ZF Test, HIV Detection | 82 N - - HS Assay, Genotype, HIV Drug Resistance, In Vitro _(verified: each item appears in the quote below)_
- **Product:** SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit | SD Bioline HIV 1/2 3/0 test kit _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II | Class II | Class II | Class II | Class II | class II _(verified: each item appears in the quote below)_

## What the source says

> Standard Diagnostics, Inc Date Published : 05/17/2012 156-68 Hagai-Ri, Giheung-Eup, Yongin-Ei , Kyonggi-Do, KOREA (THE REPUBLIC OF) 57 V - - 11 Human Immunodeficiency Virus Type 1 Date Published: 05/17/2012 Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II 57 V - - 13 Human Immunodeficiency Virus Type 2 Date Published: 05/17/2012 Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II 57 V - - 14 Human Immunodeficiency Virus Types 1 & 2 Date Published: 05/17/2012 Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II 81 M - - TK Kit, Sample Collection, HIV Date Published: 05/17/2012 Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II 81 M - - TL Monitor, Test, HIV-1 Date Published: 05/17/2012 Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II 81 M - - VZ System, Test, Home, HIV-1 Date Published: 05/17/2012 Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II 82 M - - ZF Test, HIV Detection Date Published: 05/17/2012 Desc: SD Bioline HIV 1/2 3/0 test kit Notes: Class II 82 N - - HS Assay, Genotype, HIV Drug Resistance, In Vitro Date Published: 05/17/2012 Desc: SD Bioline HIV 1/2 3/0 test kit Notes: class II

## 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/).