In-Vitro Diagnostic Medical Device in Zambia

32 products registered with ZAMRA — 32 active

Brand / Product	Reg. No.	Holder	Status	Expires
Wantai HIV Urine self-test	ZAMRA-MDR-26-134	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.	active	8 Jul 2031
EzDx Malaria Pan/Pf RapidDetection Kit	ZAMRA-MDR-26-136	ADVY CHEMICAL PRIVATE LIMITED	active	8 Jul 2031
Pentra C200, Pentra 400, and Pentra C400 (Horiba Chemistry Analyzers)	ZAMRA-MDR-26-132	Sonergy Diagnostics Limited	active	8 Jul 2031
E7 Protein Test Kit (Colloidal Gold Method)	ZAMRA-MDR-26-139	Lasec International (Pty) Ltd	active	8 Jul 2031
HORIBA	ZAMRA-MDR-26-133	Sonergy Diagnostics Limited	active	8 Jul 2031
Determine™ Antenatal Care Panel	ZAMRA-MDR-26-121	Abbott Rapid Dx International Limited	active	3 Jun 2031
H. Pylori Rapid test	ZAMRA-MDR-26-99	Nymak Pharma Pvt. Ltd.	active	11 Apr 2031
SD CodeFree™ Blood Glucose Monitoring System	ZAMRA-MDR-26-52	SD Biosensor, Inc.	active	3 Apr 2031
SD CodeFree™ Blood Glucose Test Strip	ZAMRA-MDR-26-53	SD Biosensor, Inc.	active	3 Apr 2031
SYPHILIS DEVICE	ZAMRA-MDR-26-56	Medsource Ozone Biomedicals Pvt. Ltd.	active	3 Apr 2031
H. pylori antibody rapid test kit	ZAMRA-MDR-26-59	Medsource Ozone Biomedicals Pvt. Ltd.	active	3 Apr 2031
Malaria PF Antigen test	ZAMRA-MDR-26-54	Medsource Ozone Biomedicals Pvt. Ltd.	active	3 Apr 2031
Horiba Micros ES60 Hematology Analyzer	ZAMRA-MDR-26-45	Sonergy Diagnostics Limited	active	2 Apr 2031
TrinScreen HIV	ZAMRA-MDR-26-25	Trinity Biotech Manufacturing Ltd	active	27 Feb 2031
STANDARD Q Malaria P.f Ag	ZAMRA-MDR-25-128	SD BIOSENSOR INC	active	29 Aug 2030
STANDARD Q HIV/Syphilis Combo Test	ZAMRA-MDR-25-129	SD BIOSENSOR INC	active	29 Aug 2030
Panbio™ HIV Verification Test	ZAMRA-MDR-25-94	Abbott Rapid Dx International Limited	active	22 Jun 2030
AI100 with ShonitTM	ZAMRA-MDR-25-68	Triage Healthcare	active	22 Mar 2030
OROSOL	ZAMRA-MDR-25-41	Hetero Labs Limited	active	15 Jan 2030
ALLERSPRAY	ZAMRA-MDR-25-42	Hetero Labs Limited	active	15 Jan 2030
PREG CLEAR	ZAMRA-MDR-25-40	Sidak Life care pvt ltd	active	15 Jan 2030
BIOCREDIT 2nd generation Malaria Ag Pf(pLDH/HRPII)	ZAMRA-MDR-25-46	Rapigen, Inc.	active	15 Jan 2030
AviSure Syphilis Rapid Test	ZAMRA-MDR-25-30	Prime Pharmaceuticals Ltd	active	9 Jan 2030
Prega News	ZAMRA-MDR-24-82	Mankind Pharma Ltd	active	30 Dec 2029
AVISURE HCV Ab RAPID TEST	ZAMRA-MDR-24-73	Prime Pharmaceuticals Ltd	active	20 Nov 2029
PARAHIT f Ver 1.0 RAPID TEST FOR P.FALCIPARUM MALARIA_DEVICE TEST KIT	ZAMRA-MDR-24-75	ARKRAY HEALTHCARE PVT LTD	active	20 Nov 2029
Prega News Advance	ZAMRA-MDR-24-74	Mankind Pharma Ltd	active	20 Nov 2029
Meriscreen Malaria Pf HRP-II Ag	ZAMRA-MDR-24-02	Meril Diagnostics Private Limited	active	31 Jul 2029
MERISCREEN Malaria Pf Pv Ag	ZAMRA-MDR-24-01	Meril Diagnostics Private Limited	active	31 Jul 2029
Meriscreen HIV 1-2 WB	ZAMRA-MDR-24-45	Meril Diagnostics Private Limited	active	5 Jun 2029
MERISCREEN Malaria Pf Pan Ag	ZAMRA-MDR-24-44	Meril Diagnostics Private Limited	active	5 Jun 2029
Panbio COVID-19 Ag Self-Test	ZAMRA-MDR-24-38	Abbott Rapid Diagnostics Jena GmbH	active	28 Apr 2029

In-Vitro Diagnostic Medical Device — ZAMRA Registration Details

ZAMRA (Zambia) has 32 registered products containing In-Vitro Diagnostic Medical Device, of which 32 are currently active. Data is sourced directly from the official ZAMRA drug register and refreshed daily.

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