# Genelabs Diagnostics Pte Ltd. · 89-08 · SINGAPORE — FDA import alert red lists: firms subject to detention without physical examination

For Genelabs Diagnostics Pte Ltd. · 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 HEV IgM. ELISA; product code is 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 83 L - - YR Campylobacter Pylori | 83 - - - -- Microbiology; date published is 09/16/2009; address is Singapore Science Park , 85 Science Park Drive; #04-01 The Cavendish , Singapore, SINGAPORE, verified against its source on 2026-09-16.

- **Firm:** Genelabs Diagnostics Pte Ltd. _(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:** Singapore Science Park , 85 Science Park Drive; #04-01 The Cavendish , Singapore, SINGAPORE _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. | 83 L - - YR Campylobacter Pylori | 83 - - - -- Microbiology _(verified: each item appears in the quote below)_
- **Product:** HEV IgM. ELISA _(verified: appears in the quote below)_
- **FDA notes:** OraScreen HIV Rapid Test Kits 8/13/1997 HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201. | Helico Blot 2.0; 8/13/1997 | 8/13/1997 _(verified: each item appears in the quote below)_

## What the source says

> Genelabs Diagnostics Pte Ltd. Date Published : 09/16/2009 Singapore Science Park , 85 Science Park Drive; #04-01 The Cavendish , Singapore, SINGAPORE 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. Date Published: 09/16/2009 Notes: OraScreen HIV Rapid Test Kits 8/13/1997 HIV Diagnostic Kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the US through the mail and may be entered as Asamples@ or for Apersonal usa@. The contents may be labeled Afor investigational use@ for Aresearch use@ or Afor export only @. The test kits could present a serious hazard to the public health; including possible HIV transmission to partners and delayed access to medical care due to mis-diagnosed false negative tests. If entries are encounted; contact CBER Import/Export team at 301-827-6201. 83 L - - YR Campylobacter Pylori Date Published: 09/16/2009 Notes: Helico Blot 2.0; 8/13/1997 83 - - - -- Microbiology Date Published: 01/23/2019 Desc: HEV IgM. ELISA Notes: 8/13/1997

## 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/).