Standard Diagnostics, Inc · 89-08 · KOREA (THE REPUBLIC OF)
For Standard Diagnostics, Inc, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 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 2026-09-30.
- 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)
— 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.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html