DRAP REGISTERED MEDICAL DEVICE
Rubella IgM (CLIA) is registered with DRAP under number MDIR-0007082 as a Class C (moderate to high risk) medical device, imported. The listed holder is Nextek Healthcare. It is listed as valid until 15 Sep 2029.
Screening result
MDIR-0007082
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00619
| Device | Rubella IgM (CLIA) |
|---|---|
| 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 | 16 Sep 2024 |
| Renewal date | 15 Sep 2029 |
| Licence | ELI-00619 |
Specifications
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Screened 5 Oct 2026, 07:40 (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-0009878 | Elecsys Rubella IgM [CAT #: 09755837190 Pack size: 100 Tests] | Class C | Roche Pakistan Ltd. |
| MDIR-0009565 | Chorus Rubella IgG [81030] | Class C | Future Scientific |
| MDIR-0009566 | Chorus Rubella IgM [81031] | Class C | Future Scientific |
| MDIR-0009292 | Bioplex 2200 MMRV 1gG (Measles, Mumps, Rubella, Varicella zoster virus IgG antibody IVD Kit) | Class C | Chemical House |
| MDIR-0008492 | MINDRAY Rubella Virus IgG (CLIA) | Class C | MR Medical Pakistan Pvt Ltd |
| MDIR-0008494 | MINDRAY Rubella Virus IgM (CLIA) | Class C | MR Medical Pakistan Pvt Ltd |
| MDIR-0007979 | Bioplex 2200 ToRC IgM (Toxoplasma IgM, Rubella IgM, CMV IgM) | Class B | Chemical House |
| MDIR-0006177 | LIAISON RUBELLA IgG II (REF. No. 317260) LIAISON Control RUBELLA IgG II (REF. No. 317261) | Class C | Sind Medical Stores |
| MDIR-0006178 | LIAISON RUBELLA IgM (REF. No. 310730) LIAISON Control RUBELLA IgM (REF. No. 310731) | Class C | Sind Medical Stores |
| MDIR-0005731 | VITROS Immunodiagnostic Product Rubella IgG Reagent & Calibrator | Class C | 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.