Sallamander Concepts CC · 89-08 · SOUTH AFRICA
For Sallamander Concepts CC, import alert is 89-08; country is SOUTH AFRICA; 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)"; 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 listed twice: 09/07/2010 and 09/16/2009; address is listed twice: 103 Harvest Crescent , Lynnwood Pretoria, Gauteng SOUTH AFRICA and Box 29054 , Sunnyside, SOUTH AFRICA, verified against its source on 2026-09-30.
- Firm
- Sallamander Concepts CC 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
- SOUTH AFRICA verified
- Address
- 103 Harvest Crescent , Lynnwood Pretoria, Gauteng SOUTH AFRICA verified
- Box 29054 , Sunnyside, SOUTH AFRICA also listed
- Date published
- 09/07/2010 verified
- 09/16/2009 also listed
- 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 each item verified
- Product
- Sanitoets Urine test strips | Sanitoets Prostate home Test | Sanitoets Malaria Home test each item verified
- FDA notes
- Class II | Class III | Class II each item verified
What the source says
Sallamander Concepts CC Date Published : 09/07/2010 103 Harvest Crescent , Lynnwood Pretoria, Gauteng SOUTH AFRICA
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-22
The same source also states
Sallamander Concepts Cc Date Published : 09/16/2009 Box 29054 , Sunnyside, SOUTH AFRICA
— accessdata.fda.gov, retrieved 2026-09-22
Product code
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 - - - -- 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. 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
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html