DRAP REGISTERED MEDICAL DEVICE
Lactate FS (Lactate) is registered with DRAP under number MDIR-0008653 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-0008653 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00619
| Device | Lactate FS (Lactate) |
|---|---|
| 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
No supplier specifications yet.
Supplier of this device? Add specifications (free during launch)
Sign in or create a free account to add specifications.
Screened 5 Oct 2026, 13:26 (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-0009806 | Biosystems Lactate Dehydrogenase LDH | Class B | Diag. M (Pvt) Limited |
| MDMR-000421 | Medisol CAPD 2 with drainage Bag (Dialysis Solution with 1.5% w/v Glucose) Composition: Sodium Chloride 5.786g… | Class C | Medipak Ltd. |
| MDMR-000422 | Medisol CAPD 3 with drainage Bag (Dialysis Solution with 4.25% w/v Glucose) Composition: Sodium Chloride 5.786g… | Class C | Medipak Ltd. |
| MDMR-000423 | Medisol CAPD 4 with drainage Bag (Dialysis Solution with 2.27% w/v Glucose) Composition: Sodium Chloride 5.786g… | Class C | Medipak Ltd. |
| MDIR-0006531 | ZYBIO (Lactate Dehydrogenase Isoenzyme 1 kit rate method) [6x48T/Kit, 6x64T/Kit, | Class C | Zybio Medical Pakistan (SMC-Private) Limited |
| MDIR-0004170 | Lactate Dehydrogenase. (2P56-22), (2P56-42) | Class B | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0004025 | Lactate Dehydrogenase2 [04T9920, 04T9930] | Class B | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0004029 | Lactate Dehydrogenase2 [04T0320, 04T0330] | Class B | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0003829 | Alinity c Gamma-Glutamyl Transferase Reagent Kit [07P7320, 07P7330] Alinity c Amylase Reagent Kit [07P5820] Alinity c… | Class B | Abbott Laboratories(Pakistan) Ltd |
| MDIR-0003810 | Gamma-Glutamyl Transferase Lactate Dehydrogenase Amylase | Class B | Abbott Laboratories(Pakistan) Ltd |
Corrections
Is something on this page wrong? Report a correction
Corrections are checked against the evidence before anything changes on this page.
Screen another number
Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.