# Jal Innovations · 89-08 · SINGAPORE — FDA import alert red lists: firms subject to detention without physical examination

For Jal Innovations · 89-08 · SINGAPORE, 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 SINGAPORE; 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 Oral Swab Rapid Screen Test | iCare HIV 1&2 Rapid Screen Test | iCare One-Step HIV 1/2 Oral Fluid Test | iCare One-Step HIV 1/2 Oral Fluid Test | iCare HIV 1&2 Rapid Screen Test | iCare HIV 1&2 Oral Swab Rapid Screen 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 2026-09-16.

- **Firm:** Jal Innovations _(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:** SINGAPORE _(verified: appears in the quote below)_
- **Address:** 190 Middle Road , Fortune CentreCENTRE , Singapore, SINGAPORE _(verified: appears in the quote below)_
- **Date published:** 10/04/2018 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 Oral Swab Rapid Screen Test | iCare HIV 1&2 Rapid Screen Test | iCare One-Step HIV 1/2 Oral Fluid Test | iCare One-Step HIV 1/2 Oral Fluid Test | iCare HIV 1&2 Rapid Screen Test | iCare HIV 1&2 Oral Swab Rapid Screen Test _(verified: each item appears in the quote below)_

## What the source says

> Jal Innovations Date Published : 10/04/2018 190 Middle Road , Fortune CentreCENTRE , Singapore, SINGAPORE 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 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 83 - - - -- Microbiology Date Published: 10/04/2018 Desc: iCare One-Step HIV 1/2 Oral Fluid 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

## 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/).