DRAP REGISTERED MEDICAL DEVICE
HBeAg (CLIA) 130210011M, 130610011M is registered with DRAP under number MDIR-0006620 as a Class D (high risk) medical device, imported. The listed holder is Nextek Healthcare. It is listed as valid until 7 Apr 2029.
Screening result
MDIR-0006620 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00619
| Device | HBeAg (CLIA) 130210011M, 130610011M |
|---|---|
| Class | D |
| 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 6 Oct 2026, 08:31 (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-0006607 | Syphilis (CLIA) 130269003M, 130669003M | Class C |
| MDIR-0006608 | Total PSA (CLIA) 130201004M, 130601004M | Class C |
| MDIR-0006609 | Tacrolimus (CLIA) 130257003M, 130657003M | Class C |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0005666 | Mindray HBeAG Kits | Class D | MR Medical Pakistan Pvt Ltd |
| MDIR-0004500 | HISCL HbeAg Assay Kit CU-839-537 (Along with) HISCL HbeAg Calibrator AN-056-324 | Class D | S. Ejazuddin & Co |
| MDIR-0002179 | Alinity i HBeAg Kit | Class D | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0001206 | Vitros Immunodiagnostic Products HBeAg Kit | Class D | Seico Scientific Traders |
| MDIR-0000361 | ADVIA Centaur HBeAg Kit | Class D | Hoora Pharma (Pvt) Ltd |
| MDIR-0000375 | Atellica IM HBeAg Kit | Class D | Hoora Pharma (Pvt) Ltd |
| MDIR-0000192 | Cobas Elecsys HBeAg Kit | Class D | Roche Pakistan Ltd. |
| MDIR-0000028 | ARCHITECT HBeAg Kit | Class D | Abbott Laboratories(Pakistan) 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.