DRAP REGISTERED MEDICAL DEVICE
Myoglobin (CLIA) 130256003M, 130656003M [100 Test Kit 50 Test Kit] is registered with DRAP under number MDIR-0006779 as a Class C (moderate to high risk) medical device, imported. The listed holder is Nextek Healthcare. It is listed as valid until 15 Apr 2029.
Screening result
MDIR-0006779 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00619
| Device | Myoglobin (CLIA) 130256003M, 130656003M [100 Test Kit 50 Test Kit] |
|---|---|
| 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 Apr 2024 |
| Renewal date | 15 Apr 2029 |
| Licence | ELI-00619 |
Specifications
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Screened 6 Oct 2026, 19:25 (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.
| MDMR-000520 | * GLOW Myoglobin Fluorescence Immunochromatograp hy [40 pcs / pack] | Class C | Lab Diagnostic Systems (SMC) Pvt Ltd |
| MDIR-0008880 | iFlash- Myoglobin (CLIA) | Class C | Martin Dow Specialities (Pvt) Ltd. |
| MDIR-0007654 | ARCHITECT STAT Myoglobin Reagent Kit 2K43-20/25: ARCHITECT STAT Myoglobin Calibrators 2K43-01 ARCHITECT STAT Myoglobin Controls 2K43-10 | Class C | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0006820 | Elecsys Myoglobin Test Kit | Class C | Roche Pakistan Ltd. |
| MDIR-0006504 | ZYBIO (Troponin T/CK-MB/Myoglobin Assay immunofluroscence) [1x25T/Kit, 2x25T/Kit, 4x25T/Kit, 6x25T/Kit, 8x25T/Kit] | Class C | Zybio Medical Pakistan (SMC-Private) Limited |
| MDIR-0006288 | MINDRAY (Myoglobin) (CLIA) | Class C | MR Medical Pakistan Pvt Ltd |
| MDIR-0005585 | TINA-QUANT MYOGLOBIN GEN 2 (MYO2) IVD Kit | Class C | Roche Pakistan Ltd. |
| MDIR-0005474 | Lifotronic Myoglobin (e CLIA) | Class C | MOODY Global Services |
| MDIR-0005475 | Lifotronic Myoglobin Assay kits (Lateral flow immunoassay) | Class C | MOODY Global Services |
| MDIR-0005476 | Lifotronic Myoglobin STAT (MYO STAT) e CLIA | Class C | MOODY Global Services |
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.