DRAP REGISTERED MEDICAL DEVICE
Syphilis (CLIA) 130269003M, 130669003M is registered with DRAP under number MDIR-0006607 as a Class C (moderate to high risk) medical device, imported. The listed holder is Nextek Healthcare. It is listed as valid until 7 Apr 2029.
Screening result
MDIR-0006607
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00619
| Device | Syphilis (CLIA) 130269003M, 130669003M |
|---|---|
| Class | C |
| Listed holder | Nextek Healthcare |
| Holder address | Plot No. 24-C, Lane-9, Khayaban-e-Ghazi, D.H.A. Phase 6, Karachi |
| Manufacturing site | M/s Shenzhen New Industries Biomedical Engineering Co., Ltd No.23, Jinxiu East Road, Pingshan District, 518122 Shenzhen, P.R. China |
| Issued | 8 Apr 2024 |
| Renewal date | 7 Apr 2029 |
| Licence | ELI-00619 |
Specifications
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Screened 4 Oct 2026, 22:10 (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.
| MDIR-0006598 | AFP (CLIA) 130201033M, 130601033M | Class C |
| MDIR-0006599 | CA 125 (CLIA) 130201031M, 130601031M | Class C |
| MDIR-0006600 | CRP (CLIA) 130266002M, 130666002M | Class C |
| MDIR-0006601 | cTnI (CLIA) 130256002M, 130656002M | Class C |
| MDIR-0006602 | Cyclosporine (CLIA) 130257001M, 130657001M | Class C |
| MDIR-0006603 | D-Dimer (CLIA) 130256008M, 130656008M | Class C |
| MDIR-0006604 | Insulin (CLIA) 130255002M, 130655002M | Class C |
| MDIR-0006605 | NT-proBNP (CLIA) 130256004M, 130656004M | Class C |
| MDIR-0006606 | PCT (CLIA) 130266001M, 130666001M | Class C |
| MDIR-0006608 | Total PSA (CLIA) 130201004M, 130601004M | Class C |
| MDIR-0006609 | Tacrolimus (CLIA) 130257003M, 130657003M | Class C |
| MDIR-0006610 | f-PSA (CLIA) 1130201005M, 130601005M | Class C |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0009838 | Diagnostar Syphilis Ab Rapid Test (Cassette) (Serum /Plasma) [GCSYP-402a] | Class C | Gulf Marketing International |
| MDIR-0009294 | Bioplex 2200 Syphilis Total & RPR (Treponema pallidum total antibody and reagin antibody IVD kit) | Class C | Chemical House |
| MDIR-0008029 | Onsite Syphilis Ab Combo Rapid Test Kit [R0031C] | Class C | Mian Scientific Corporation (Pvt) Ltd. |
| MDIR-0007938 | Hindering Syphilis Rapid Test Cassette | Class C | Zenith International |
| MDIR-0007453 | Flowflex Syphilis Rapid Test Cassette | Class C | Shams Scientific Traders |
| MDMR-000346 | R-test Syphilis Ab Self Test Syphilis Antibodies Detection Kit (Colloidal Gold) | Class C | Lab Diagnostic Systems (SMC) Pvt. Ltd. |
| MDIR-0006479 | Realy (Syphilis Rapid Test Device) | Class C | MOODY Global Services |
| MDIR-0006482 | Realy (Syphilis Rapid Test Device) | Class C | MOODY Global Services |
| MDIR-0006391 | Healgen Syphilis Ab Rapid Test Cassette (Serum/Plasma) (Syphilis Ab Rapid Test) [GCSYP-302a] | Class C | Shams Scientific Traders |
| MDIR-0005730 | VITROS Immunodiagnostics Product Syphilis TPA Reagent | Class D | Martin Dow Marker Specialities (Pvt) Ltd. |
Corrections
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.