Sallamander Concepts (Pty) Ltd · 89-08 · SOUTH AFRICA (359 Church Street , Pretoria, Gauteng SOUTH AFRICA)
For Sallamander Concepts (Pty) Ltd (359 Church Street , Pretoria, Gauteng SOUTH AFRICA), 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 09/07/2010; address is 359 Church Street , Pretoria, Gauteng SOUTH AFRICA, verified against its source on 2026-09-30.
- Firm
- Sallamander Concepts (Pty) Ltd 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
- 359 Church Street , Pretoria, Gauteng SOUTH AFRICA verified
- Date published
- 09/07/2010 verified
- 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 (Pty) Ltd Date Published : 09/07/2010 359 Church Street , Pretoria, Gauteng SOUTH AFRICA
— accessdata.fda.gov, retrieved 2026-09-15
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 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html