Reference Source

Jal Innovations · 89-08 · SINGAPORE

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
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 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 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

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