# Globalemed Sa Pty Ltd · 89-08 · SOUTH AFRICA — FDA import alert red lists: firms subject to detention without physical examination

For Globalemed Sa Pty Ltd · 89-08 · SOUTH AFRICA, 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 SOUTH AFRICA; product is HIV Test Kit | HIV Test Kit | HIV Test Kit | HIV Test Kit | HIV Test Kit | HIV Test Kit; product code is 81 M - - TK Kit, Sample Collection, HIV | 81 M - - TL Monitor, Test, HIV-1 | 81 M - - VZ System, Test, Home, HIV-1 | 82 M - - TL Monitor, Test, HIV-1 | 82 M - - VZ System, Test, Home, HIV-1 | 82 M - - ZF Test, HIV Detection; date published is 01/23/2019; address is Unit 9 Montague Square Montague , Garden , Cape Town, SOUTH AFRICA, verified against its source on 2026-09-16.

- **Firm:** Globalemed Sa Pty 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:** SOUTH AFRICA _(verified: appears in the quote below)_
- **Address:** Unit 9 Montague Square Montague , Garden , Cape Town, SOUTH AFRICA _(verified: appears in the quote below)_
- **Date published:** 01/23/2019 _(verified: appears in the quote below)_
- **Product code:** 81 M - - TK Kit, Sample Collection, HIV | 81 M - - TL Monitor, Test, HIV-1 | 81 M - - VZ System, Test, Home, HIV-1 | 82 M - - TL Monitor, Test, HIV-1 | 82 M - - VZ System, Test, Home, HIV-1 | 82 M - - ZF Test, HIV Detection _(verified: each item appears in the quote below)_
- **Product:** HIV Test Kit | HIV Test Kit | HIV Test Kit | HIV Test Kit | HIV Test Kit | HIV Test Kit _(verified: each item appears in the quote below)_
- **FDA notes:** Class III; 9/18/2009 | Class III; 9/18/2009 | Class III; 9/18/2009 | Class III; 9/18/2009 | Class III; 9/18/2009 | Class III; 9/18/2009 _(verified: each item appears in the quote below)_

## What the source says

> Globalemed Sa Pty Ltd Date Published : 01/23/2019 Unit 9 Montague Square Montague , Garden , Cape Town, SOUTH AFRICA 81 M - - TK Kit, Sample Collection, HIV Date Published: 01/23/2019 Desc: HIV Test Kit Notes: Class III; 9/18/2009 81 M - - TL Monitor, Test, HIV-1 Date Published: 01/23/2019 Desc: HIV Test Kit Notes: Class III; 9/18/2009 81 M - - VZ System, Test, Home, HIV-1 Date Published: 01/23/2019 Desc: HIV Test Kit Notes: Class III; 9/18/2009 82 M - - TL Monitor, Test, HIV-1 Date Published: 01/23/2019 Desc: HIV Test Kit Notes: Class III; 9/18/2009 82 M - - VZ System, Test, Home, HIV-1 Date Published: 01/23/2019 Desc: HIV Test Kit Notes: Class III; 9/18/2009 82 M - - ZF Test, HIV Detection Date Published: 01/23/2019 Desc: HIV Test Kit Notes: Class III; 9/18/2009

## 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/).