Globalemed Sa Pty Ltd · 89-08 · SOUTH AFRICA
For Globalemed Sa 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html