DRAP REGISTERED MEDICAL DEVICE
Immunoglobulin E FS (Immunoglobulin E) is registered with DRAP under number MDIR-0008639 as a Class B (low to moderate risk) medical device, imported. The listed holder is Nextek Healthcare. It is listed as valid until 27 Mar 2030.
Screening result
MDIR-0008639 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00619
| Device | Immunoglobulin E FS (Immunoglobulin E) |
|---|---|
| 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 DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany |
| Issued | 28 Mar 2025 |
| Renewal date | 27 Mar 2030 |
| Licence | ELI-00619 |
Specifications
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Screened 6 Oct 2026, 15:03 (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.
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| MDIR-0001189 | VIDAS anti HEV IgM (Hepatitis E virus immunoglobulin M (IgM) antibody IVD) | Class C | Global Marketing Services |
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| MDIR-0000553 | VIDAS RUB IGM (Rubella virus immunoglobulin M (IgM) antibody IVD) 30214 | Class C | Global Marketing Services |
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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.