Jal Innovations · 89-08 · SINGAPORE
For Jal Innovations, import alert is 89-08; country is SINGAPORE; 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 iCare HIV 1&2 Rapid Screen Test | iCare One-Step HIV 1/2 Oral Fluid Test | iCare HIV 1&2 Oral Swab Rapid Screen Test | iCare HIV 1&2 Rapid Screen Test | iCare One-Step HIV 1/2 Oral Fluid Test | iCare HIV 1&2 Oral Swab Rapid Screen Test | iCare HIV 1&2 Rapid Screen Test | iCare HIV 1&2 Oral Swab Rapid Screen Test | iCare One-Step HIV 1/2 Oral Fluid Test; product code is 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 82 - - - -- Immunology | 82 - - - -- Immunology | 82 - - - -- Immunology | 83 - - - -- Microbiology | 83 - - - -- Microbiology | 83 - - - -- Microbiology; date published is 10/04/2018; address is 190 Middle Road , Fortune CentreCENTRE , Singapore, SINGAPORE, verified against its source on 2026-09-30.
- Firm
- Jal Innovations 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
- SINGAPORE verified
- Address
- 190 Middle Road , Fortune CentreCENTRE , Singapore, SINGAPORE verified
- Date published
- 10/04/2018 verified
- Product code
- 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 82 - - - -- Immunology | 82 - - - -- Immunology | 82 - - - -- Immunology | 83 - - - -- Microbiology | 83 - - - -- Microbiology | 83 - - - -- Microbiology each item verified
- Product
- iCare HIV 1&2 Rapid Screen Test | iCare One-Step HIV 1/2 Oral Fluid Test | iCare HIV 1&2 Oral Swab Rapid Screen Test | iCare HIV 1&2 Rapid Screen Test | iCare One-Step HIV 1/2 Oral Fluid Test | iCare HIV 1&2 Oral Swab Rapid Screen Test | iCare HIV 1&2 Rapid Screen Test | iCare HIV 1&2 Oral Swab Rapid Screen Test | iCare One-Step HIV 1/2 Oral Fluid Test each item verified
What the source says
Jal Innovations Date Published : 10/04/2018 190 Middle Road , Fortune CentreCENTRE , Singapore, SINGAPORE
— accessdata.fda.gov, retrieved 2026-09-22
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 and Product
57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. Date Published: 10/04/2018 Desc: iCare HIV 1&2 Rapid Screen Test 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. Date Published: 10/04/2018 Desc: iCare One-Step HIV 1/2 Oral Fluid Test 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. Date Published: 10/04/2018 Desc: iCare HIV 1&2 Oral Swab Rapid Screen Test 82 - - - -- Immunology Date Published: 10/04/2018 Desc: iCare HIV 1&2 Rapid Screen Test 82 - - - -- Immunology Date Published: 10/04/2018 Desc: iCare One-Step HIV 1/2 Oral Fluid Test 82 - - - -- Immunology Date Published: 10/04/2018 Desc: iCare HIV 1&2 Oral Swab Rapid Screen Test 83 - - - -- Microbiology Date Published: 10/04/2018 Desc: iCare HIV 1&2 Rapid Screen Test 83 - - - -- Microbiology Date Published: 10/04/2018 Desc: iCare HIV 1&2 Oral Swab Rapid Screen Test 83 - - - -- Microbiology Date Published: 10/04/2018 Desc: iCare One-Step HIV 1/2 Oral Fluid Test
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html