Intact PTH - DRAP MDIR-0008735 (Class B)

DRAP REGISTERED MEDICAL DEVICE

Intact PTH (CLIA) (Parathyroid Hormone) 25-OH Vitamin D (CLIA) (25-Hydroxyvitamin D) is registered with DRAP under number MDIR-0008735 as a Class B (low to moderate risk) medical device, imported. The listed holder is Nextek Healthcare. It is listed as valid until 3 Apr 2030.

Screening result

i
Imported device, registered with DRAP as Class B (low to moderate risk)
MDIR-0008735 · the class is taken from DRAP's list for this number
✓
Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
✓
Listed valid until 3 Apr 2030
✓
Holder has a DRAP import licence on file
ELI-00619
DeviceIntact PTH (CLIA) (Parathyroid Hormone) 25-OH Vitamin D (CLIA) (25-Hydroxyvitamin D)
ClassB
Listed holderNextek Healthcare
Holder addressPlot No. 24-C, Lane-9, Khayaban-e-Ghazi, D.H.A. Phase 6, Karachi.
Manufacturing siteM/s Shenzhen New Industries Biomedical Engineering Co., Ltd. No.23, Jinxiu East Road, Pingshan District, 518122 Shenzhen, P.R.China
Issued4 Apr 2025
Renewal date3 Apr 2030
LicenceELI-00619

Specifications

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Screened 5 Oct 2026, 13:30 (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-0006598AFP (CLIA) 130201033M, 130601033MClass C
MDIR-0006599CA 125 (CLIA) 130201031M, 130601031MClass C
MDIR-0006600CRP (CLIA) 130266002M, 130666002MClass C
MDIR-0006601cTnI (CLIA) 130256002M, 130656002MClass C
MDIR-0006602Cyclosporine (CLIA) 130257001M, 130657001MClass C
MDIR-0006603D-Dimer (CLIA) 130256008M, 130656008MClass C
MDIR-0006604Insulin (CLIA) 130255002M, 130655002MClass C
MDIR-0006605NT-proBNP (CLIA) 130256004M, 130656004MClass C
MDIR-0006606PCT (CLIA) 130266001M, 130666001MClass C
MDIR-0006607Syphilis (CLIA) 130269003M, 130669003MClass C
MDIR-0006608Total PSA (CLIA) 130201004M, 130601004MClass C
MDIR-0006609Tacrolimus (CLIA) 130257003M, 130657003MClass C

Similar devices from other companies

Same device type listed by other holders, useful when comparing suppliers.

MDIR-0003969Alinity i Intact PTHClass BAbbott Laboratories(Pakistan) Ltd
MDIR-0003828Architect Intact PTH Reagent Kit Calibrator & Controls. [8K25-28, 8K25-04, 8K25-13]Class BAbbott Laboratories(Pakistan) Ltd
MDIR-0003543VITROS Syphilis Intact PTH NTx Reagent Pack, Intact PTH NTx Calibrator and Intact PTH NTx Controls…Class BSeico Scientific Traders
MDIR-0002678IDS-iSYS CTX-1 Cross Laps A, IDS-iSYS CTX-1 (Cross Laps A) control set, IDS-iSYS 25-Hydroxy Vitamin DS,…Class BFuture Scientific

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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.