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

For Sallamander Concepts 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 Sanitoets Urine test strips | Sanitoets Prostate home test | Sanitoets Malaria Home test; product code is 75 - - - -- Chemistry | 82 M - - TG Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer from Benign Cond | 83 O - - AX Plasmodium spp. Detection reagents; date published is 09/07/2010; address is 320 The Hillside Lynwood , Hatfield, SOUTH AFRICA, verified against its source on 2026-09-16.

- **Firm:** Sallamander Concepts 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:** 320 The Hillside Lynwood , Hatfield, SOUTH AFRICA _(verified: appears in the quote below)_
- **Date published:** 09/07/2010 _(verified: appears in the quote below)_
- **Product code:** 75 - - - -- Chemistry | 82 M - - TG Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer from Benign Cond | 83 O - - AX Plasmodium spp. Detection reagents _(verified: each item appears in the quote below)_
- **Product:** Sanitoets Urine test strips | Sanitoets Prostate home test | Sanitoets Malaria Home test _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class III | Class II _(verified: each item appears in the quote below)_

## What the source says

> Sallamander Concepts Pty Ltd Date Published : 09/07/2010 320 The Hillside Lynwood , Hatfield, SOUTH AFRICA 75 - - - -- Chemistry Date Published: 09/07/2010 Desc: Sanitoets Urine test strips Notes: Class II 82 M - - TG Test, Prostate Specific Antigen, Free (Noncomplexed) to Distinguish Prostate Cancer from Benign Cond Date Published: 09/07/2010 Desc: Sanitoets Prostate home test Notes: Class III 83 O - - AX Plasmodium spp. Detection reagents Date Published: 09/07/2010 Desc: Sanitoets Malaria Home test Notes: Class II

## 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/).