AfricaRegulatory
African Pharmaceutical Regulatory Intelligence
In-Vitro Diagnostic Medical Device
32 registrations across 1 African market— 32 active
Markets with In-Vitro Diagnostic Medical Device
Recent registrations
| Brand / Product | Market | Holder | Status | Expires |
|---|---|---|---|---|
| E7 Protein Test Kit (Colloidal Gold Method) | 🇿🇲Zambia | Lasec International (Pty) Ltd | active | Jul 2031 |
| Pentra C200, Pentra 400, and Pentra C400 (Horiba Chemistry Analyzers) | 🇿🇲Zambia | Sonergy Diagnostics Limited | active | Jul 2031 |
| HORIBA | 🇿🇲Zambia | Sonergy Diagnostics Limited | active | Jul 2031 |
| Wantai HIV Urine self-test | 🇿🇲Zambia | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | active | Jul 2031 |
| EzDx Malaria Pan/Pf RapidDetection Kit | 🇿🇲Zambia | ADVY CHEMICAL PRIVATE LIMITED | active | Jul 2031 |
| Determine™ Antenatal Care Panel | 🇿🇲Zambia | Abbott Rapid Dx International Limited | active | Jun 2031 |
| H. Pylori Rapid test | 🇿🇲Zambia | Nymak Pharma Pvt. Ltd. | active | Apr 2031 |
| SD CodeFree™ Blood Glucose Test Strip | 🇿🇲Zambia | SD Biosensor, Inc. | active | Apr 2031 |
| H. pylori antibody rapid test kit | 🇿🇲Zambia | Medsource Ozone Biomedicals Pvt. Ltd. | active | Apr 2031 |
| SD CodeFree™ Blood Glucose Monitoring System | 🇿🇲Zambia | SD Biosensor, Inc. | active | Apr 2031 |
| Malaria PF Antigen test | 🇿🇲Zambia | Medsource Ozone Biomedicals Pvt. Ltd. | active | Apr 2031 |
| SYPHILIS DEVICE | 🇿🇲Zambia | Medsource Ozone Biomedicals Pvt. Ltd. | active | Apr 2031 |
| Horiba Micros ES60 Hematology Analyzer | 🇿🇲Zambia | Sonergy Diagnostics Limited | active | Apr 2031 |
| TrinScreen HIV | 🇿🇲Zambia | Trinity Biotech Manufacturing Ltd | active | Feb 2031 |
| STANDARD Q HIV/Syphilis Combo Test | 🇿🇲Zambia | SD BIOSENSOR INC | active | Aug 2030 |
| STANDARD Q Malaria P.f Ag | 🇿🇲Zambia | SD BIOSENSOR INC | active | Aug 2030 |
| Panbio™ HIV Verification Test | 🇿🇲Zambia | Abbott Rapid Dx International Limited | active | Jun 2030 |
| AI100 with ShonitTM | 🇿🇲Zambia | Triage Healthcare | active | Mar 2030 |
| PREG CLEAR | 🇿🇲Zambia | Sidak Life care pvt ltd | active | Jan 2030 |
| OROSOL | 🇿🇲Zambia | Hetero Labs Limited | active | Jan 2030 |
| BIOCREDIT 2nd generation Malaria Ag Pf(pLDH/HRPII) | 🇿🇲Zambia | Rapigen, Inc. | active | Jan 2030 |
| ALLERSPRAY | 🇿🇲Zambia | Hetero Labs Limited | active | Jan 2030 |
| AviSure Syphilis Rapid Test | 🇿🇲Zambia | Prime Pharmaceuticals Ltd | active | Jan 2030 |
| Prega News | 🇿🇲Zambia | Mankind Pharma Ltd | active | Dec 2029 |
| Prega News Advance | 🇿🇲Zambia | Mankind Pharma Ltd | active | Nov 2029 |
| AVISURE HCV Ab RAPID TEST | 🇿🇲Zambia | Prime Pharmaceuticals Ltd | active | Nov 2029 |
| PARAHIT f Ver 1.0 RAPID TEST FOR P.FALCIPARUM MALARIA_DEVICE TEST KIT | 🇿🇲Zambia | ARKRAY HEALTHCARE PVT LTD | active | Nov 2029 |
| Meriscreen Malaria Pf HRP-II Ag | 🇿🇲Zambia | Meril Diagnostics Private Limited | active | Jul 2029 |
| MERISCREEN Malaria Pf Pv Ag | 🇿🇲Zambia | Meril Diagnostics Private Limited | active | Jul 2029 |
| MERISCREEN Malaria Pf Pan Ag | 🇿🇲Zambia | Meril Diagnostics Private Limited | active | Jun 2029 |
| Meriscreen HIV 1-2 WB | 🇿🇲Zambia | Meril Diagnostics Private Limited | active | Jun 2029 |
| Panbio COVID-19 Ag Self-Test | 🇿🇲Zambia | Abbott Rapid Diagnostics Jena GmbH | active | Apr 2029 |
In-Vitro Diagnostic Medical Device in Africa — Regulatory Overview
In-Vitro Diagnostic Medical Device is registered across 1 African markets with 32 total product registrations on file. Data is sourced directly from official national drug regulatory authorities including Zambia. AfricaRegulatory refreshes this data daily from official government sources.
Of the 32 registrations, 32 (100%) are currently active. Regulatory affairs teams use AfricaRegulatory to track registration expiry dates, identify market incumbents, and monitor approval status across African markets without manual monitoring of each national regulator.