Globalemed Sa Pty Ltd · 89-08 · SOUTH AFRICA
For Globalemed Sa Pty Ltd, 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 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 2026-09-30.
- Firm
- Globalemed Sa 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
- Unit 9 Montague Square Montague , Garden , Cape Town, SOUTH AFRICA verified
- Date published
- 01/23/2019 verified
- 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 each item verified
- Product
- HIV Test Kit | HIV Test Kit | HIV Test Kit | HIV Test Kit | HIV Test Kit | HIV Test Kit each item verified
- 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 each item verified
What the source says
Globalemed Sa Pty Ltd Date Published : 01/23/2019 Unit 9 Montague Square Montague , Garden , Cape Town, 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
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html