Sallamander Concepts CC · 89-08 · SOUTH AFRICA

For Sallamander Concepts CC · 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 103 Harvest Crescent , Lynnwood Pretoria, Gauteng SOUTH AFRICA, verified against its source on 2026-09-16.

What the source says

Sallamander Concepts CC Date Published : 09/07/2010 103 Harvest Crescent , Lynnwood Pretoria, Gauteng 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

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

The same source also states

Sallamander Concepts Cc Date Published : 09/16/2009 Box 29054 , Sunnyside, SOUTH AFRICA 57 Y - - 99 Biological In-Vivo and In-Vitro Diagnostics, N.E.C. Date Published: 09/16/2009 Notes: HIV 1/2 HIV 2 Subtype O Serum; Plasma or Whole Blood Test Kit. (aka HIV/AIDS test kit) 1/29/2001. 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. 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 82 - - - -- Immunology Date Published: 09/16/2009 Notes: HIV 1/2 HIV 2 Subtype O Serum; Plasma or Whole Blood Test Kit. (aka HIV/AIDS test kit) 1/29/2001. 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 O - - AX Plasmodium spp. Detection reagents Date Published: 09/07/2010 Desc: Sanitoets Malaria Home test Notes: Class II

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

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.