DRAP registered medical device · imported

Malaria Pf Ag Rapid Test cassette

Class C (moderate to high risk) · MDIR-0006553 · Shams Scientific Traders

✓ DRAP status Listed Valid until 14 Mar 2029
Screened against DRAP's published lists

DRAP REGISTERED MEDICAL DEVICE

Malaria Pf Ag Rapid Test cassette (Whole Blood) [GCMAL(pf) 402a] is registered with DRAP under number MDIR-0006553 as a Class C (moderate to high risk) medical device, imported. The listed holder is Shams Scientific Traders. It is listed as valid until 14 Mar 2029.

Screening result

i
Imported device, registered with DRAP as Class C (moderate to high risk)
MDIR-0006553 · the class is taken from DRAP's list for this number
✓
Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
✓
Listed valid until 14 Mar 2029
✓
Holder has a DRAP import licence on file
ELI-00459
DeviceMalaria Pf Ag Rapid Test cassette (Whole Blood) [GCMAL(pf) 402a]
ClassC
Listed holderShams Scientific Traders
Holder addressOffice No 7, First Floor Sadiq Plaza, P-481-Jinnah Colony, Faisalabad
Manufacturing siteM/s Healgen Scientific LLC 3818 Fuqua street, Houston, TX 77047, USA M/s Zhejiang Orient Gene Biotech Co., Ltd., 3787, east Yangguang Avenue, Dipu street Anji 313300 Huzhou, Zhejiang, China
Issued15 Mar 2024
Renewal date14 Mar 2029
LicenceELI-00459

Specifications

No supplier specifications yet.

Supplier of this device? Add specifications (free during launch)

Sign in or create a free account to add specifications.

Screened 7 Oct 2026, 00:50 (Pakistan time). A screening aid, not an official DRAP verification.

More devices from this holder

Other DRAP registrations and enlistments listed for the same company.

MDIE-0000974MaxLife Non Sterile Latex Examination Gloves (Powder free)Class A
MDIE-0000975Non Sterile Nitrile Examination Gloves (Powder free)Class A
MDIE-0002045Maxlife Latex Examination Gloves (Powdered) [XS, S, M, L, XL]Class A
MDIR-0003632Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma) [GCTB-302a]Class C
MDIR-0003633Dengue NS1 Ag Rapid test Cassette [GCDEN(NS)-402c]Class C
MDIR-0004992Healgen HCV Hepatitis C Virus Rapid Test (Serum/Plasma) (Cassette) Healgen HCV Hepatitis C Virus Rapid Test…Class D
MDIR-0004993Healgen HIV 1/2 Human Immunodeficiency Virus Rapid Test (Serum/Plasma) Cassette HIV 1/2 Human Immunodeficiency Virus Rapid…Class D
MDIR-0005422VeroTest Salmonella Typhi H (Bacterial antigen serology test kit)Class C
MDIR-0005750RightSign HBsAg Rapid Test Cassette [IHBSG-C31]Class D
MDIR-0005751RightSign HIV 1.2.0 Rapid Test CassetteClass D
MDIR-0005752RightSign Dengue NSI Antigen Rapid Test Cassette [IDEG-C41]Class D
MDIR-0005753RightSign Malaria P.f/ P.v Antigen Rapid Test Cassette [IMPV-C52/ IMPV-C52S]Class D

Similar devices from other companies

Same device type listed by other holders, useful when comparing suppliers.

MDMR-000605Medsenso Malaria Pf/Pv Rapid Test Kit (Rapid Diagnostic Kit) [RDT-MAL]Class CMedsenso Pvt. Ltd
MDIR-0008692Onsite Malaria Pf/Pan Ag Rapid Test KitClass CMian Scientific Corporation (Pvt) Ltd.
MDIR-0007973Cure Sure Malaria P.f/Pan Rapid Test [MAL-W23M002, MAL-W11M002]Class CCure Connect Pakistan
MDIR-0008023Medicare Malaria P.f/Pan Rapid Test MDClass CMana & Co.
MDIR-0008028Onsite Malaria Pf/Pv Ab Combo Rapid Test Kit [R0111C]Class CMian Scientific Corporation (Pvt) Ltd.
MDIR-0007936Hindering Malaria P.f/P.v Rapid Test Cassette [I041-4002]Class CZenith International
MDIR-0007937Hindering Malaria P.f/Pan Rapid Test Cassette [I040-4002]Class CZenith International
MDMR-000347R-test Malaria Pf/Pan Rapid Test Malaria Antigen Detection Kit (Colloidal Gold)Class CLab Diagnostic Systems (SMC) Pvt. Ltd.
MDIR-0006768Safety-Chek Malaria Rapid Test (Malaria Pf/Pv Rapid Test) [Strip/ Cassette]Class CUnited Healthcare
MDIR-0006475Realy (Malaria p.f/pan Antigen Rapid Test Device)Class DMOODY Global Services

Corrections

Is something on this page wrong? Report a correction

Corrections are checked against the evidence before anything changes on this page.

Screen another number

Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.