DRAP REGISTERED MEDICAL DEVICE
H.pylori IgA (CLIA) (Anti-Helicobacter pylori immunoglobulin) is registered with DRAP under number MDIR-0008734 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
MDIR-0008734 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00619
| Device | H.pylori IgA (CLIA) (Anti-Helicobacter pylori immunoglobulin) |
|---|---|
| Class | B |
| 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 | 4 Apr 2025 |
| Renewal date | 3 Apr 2030 |
| Licence | ELI-00619 |
Specifications
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Screened 5 Oct 2026, 21:02 (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-0009844 | Diagnostar H.pylori Ab Rapid Test Cassette (Whole blood, serum , plasma) [GCHP-402a] | Class B | Gulf Marketing International |
| MDIR-0009679 | Vircell Helicobacter Pylori Elisa IgG [G 1022] | Class B | Med Lab Services |
| MDIR-0009683 | Vircell Helicobacter Pylori Elisa IgA [A 1022] | Class B | Med Lab Services |
| MDIR-0009688 | Bio Check H. Pylori Ag Rapid Test Cassette (Feces) [GCHP-602a] | Class B | Alfa Scientific Store |
| MDIR-0009691 | Bio Check H. Pylori Ab Rapid Test Strip (Serum / Plasma) [GCHP-401a] | Class B | Alfa Scientific Store |
| MDIR-0009617 | Ichroma H. pylori Stool Antigen [CFPC -81 | Class B | Global Healthcare |
| MDIR-0009286 | Healstone H. Pylori Ab Rapid Device Test [GCHP-302a ] | Class B | Alfa Scientific Store |
| MDIR-0009288 | Healstone H. Pylori Ag Rapid Test Cassette (Feces) [GCHP-602a ] | Class B | Alfa Scientific Store |
| MDIR-0009090 | Agilent FLEX Poly Rb a Helicobacter Pylori, RTU, 12 mL (Dako OMNIS) | Class B | Meximp Technologies |
| MDIR-0009091 | Agilent FLEX Poly Rb a Helicobacter Pylori, RTU, 12 mL | Class B | Meximp Technologies |
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.