Standard Diagnostics, Inc · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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
- Address
- 156-68 Hagai-Ri, Giheung-Eup, Yongin-Ei , Kyonggi-Do, KOREA (THE REPUBLIC OF) verified
- Date published
- 05/17/2012 verified
- 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 each item verified
- 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 each item verified
- FDA notes
- Class II | Class II | Class II | Class II | Class II | Class II | Class II | class II each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html