DRAP REGISTERED MEDICAL DEVICE
Tacrolimus (CLIA) 130257003M, 130657003M is registered with DRAP under number MDIR-0006609 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-0006609 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00619
| Device | Tacrolimus (CLIA) 130257003M, 130657003M |
|---|---|
| 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 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-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-0006638 | ARCHITECT Tacrolimus Reagent Kit 1L77-25 [ARCHITECT Tacrolimus Calibrators 1L77-01 ARCHITECT Tacrolimus Whole Blood Precipitation Reagent 1L77-55] | Class C | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0005715 | Alinity i Tacrolimus Reagent Kit 09P4220 Alinity i Tacrolimus Calibrators 09P4201 Alinity i Tacrolimus Whole Blood… | Class C | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0004512 | Dimension Tacrolimus Flex Reagent Cartridge (10700795/DF20 7) Dimension Tacrolimus Calibrator (10700796/DC20 7) | Class C | Hoora Pharma (Pvt) Ltd |
| MDIR-0004077 | Alinity i Tacrolimus Reagent Kit [09P42-20] Alinity i Tacrolimus Calibrators [09P42-01] Alinity i Tacrolimus Whole Blood… | Class C | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0001553 | ARCHITECT Tacrolimus | Class C | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0001248 | Cobas Elecsys Tacrolimus Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
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.