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Medical device registration holder

Zybio Medical Pakistan (SMC-Private) Limited

43 DRAP registrations and enlistments (10 Class A, 1 Class B, 32 Class C) · Screen a DRAP number · Device types · Companies

DRAP lists

All devices of Zybio Medical Pakistan (SMC-Private) Limited

DRAP no.DeviceClassStatus
MDIR-0006521ZYBIO (AFP Assay CLIA) [50T/Kit, 100T/Kit]CValid to Mar 2029
MDIR-0006532ZYBIO (alpha-hydroxybutyric Acid Dehydrogenase (a-HBDH) kit, rate method) [6x48T/Kit, 6x64T/KitCValid to Mar 2029
MDIR-0006527ZYBIO (Anti-Streptolysin O kit latex enhanced immunoturbidimetric Method) [6x48T/Kit, 6x64T/Kit,CValid to Mar 2029
MDIR-0006506ZYBIO (C-reactive protein Asaay immunofluroscence) [1x25T/Kit, 2x25T/Kit, 4x25T/Kit, 6x25T/Kit, 8x25T/Kit]CValid to Mar 2029
MDIR-0006533ZYBIO (C-Reactive Protein Kit, latex Enhanced Immunoturbidimetric method)CValid to Mar 2029
MDIR-0006525ZYBIO (CA 125 Assay CLIA) [50T/Kit, 100T/Kit]CValid to Mar 2029
MDIR-0006524ZYBIO (CA 15-3 Assay CLIA) [50T/Kit, 100T/Kit]CValid to Mar 2029
MDIR-0006523ZYBIO (CA 19-9 Assay CLIA) [50T/Kit, 100T/Kit]CValid to Mar 2029
MDIR-0006514ZYBIO (CA 242 Assay CLIA) [50T/Kit, 100T/Kit]CValid to Mar 2029
MDIR-0006515ZYBIO (CA 50 Assay CLIA) [50T/Kit, 100T/Kit]CValid to Mar 2029
MDIR-0006513ZYBIO (CA 72-4 Assay CLIA) [50T/Kit, 100T/Kit]CValid to Mar 2029
MDIR-0006522ZYBIO (CEA Assay CLIA) [50T/Kit, 100T/Kit]CValid to Mar 2029
MDIR-0006518ZYBIO (CK-MB Assay CLIA) [1x50T/Kit, 2x50T/Kit, 1x100T/Kit, 2x100T/Kit]CValid to Mar 2029
MDIR-0006528ZYBIO (Creatine kinase kit rate method) [6x48T/Kit, 6x64T/Kit,CValid to Mar 2029
MDIR-0006516ZYBIO (cTnI Assay CLIA) [1x50T/Kit, 2x50T/Kit, 1x100T/Kit, 2x100T/Kit]CValid to Mar 2029
MDIR-0006508ZYBIO (cTnI Assay immunofluroscence) [1T/Kit, 1x10T/Kit, 1x25T/Kit, 2x25T/Kit, 4x25T/Kit, 6x25T/Kit, 8x25T/Kit]CValid to Mar 2029
MDIR-0006517ZYBIO (D-Dimer Assay CLIA) [1x50T/Kit, 2x50T/Kit, 1x100T/Kit, 2x100T/Kit]CValid to Mar 2029
MDIR-0006507ZYBIO (D-Dimer Assay immunofluroscence) [1x25T/Kit, 2x25T/Kit, 4x25T/Kit, 6x25T/Kit 8x25T/Kit]CValid to Mar 2029
MDIR-0006526ZYBIO (D-Dimer kit latex enhanced Immunoturbidimetric method) [6x48T/Kit, 6x64T/Kit,CValid to Mar 2029
MDIR-0006510ZYBIO (HE4 Assay CLIA) [50T/Kit, 100T/Kit]CValid to Mar 2029
MDIR-0006529ZYBIO (High Sensitive C-Reactive Protein kit immunotrubidimetric method) [6x48T/Kit, 6x64T/Kit,CValid to Mar 2029
MDIR-0006530ZYBIO (Homocystein kit enzymatic method) [1x100T/Kit, 1x170T/Kit,CValid to Mar 2029
MDIR-0006531ZYBIO (Lactate Dehydrogenase Isoenzyme 1 kit rate method) [6x48T/Kit, 6x64T/Kit,CValid to Mar 2029
MDIR-0006520ZYBIO (MYO Assay CLIA) [1x50T/Kit, 2x50T/Kit, 1x100T/Kit, 2x100T/Kit]CValid to Mar 2029
MDIR-0006512ZYBIO (NSE Assay CLIA) [50T/Kit, 100T/Kit]CValid to Mar 2029
MDIR-0006519ZYBIO (NT-proBNP Assay CLIA) [25T/Kit]CValid to Mar 2029
MDIR-0006503ZYBIO (NT-proBNP Assay immunofluroscence) [25T/kit]CValid to Mar 2029
MDIR-0006502ZYBIO (PCT Asaay CLIA) [1x50T/Kit, 2x50T/Kit, 1x100T/Kit, 2x100T/Kit]CValid to Mar 2029
MDIR-0006509ZYBIO (PCT Assay Immunofluorescence) [1x25T/Kit, 2x25T/Kit, 4x25T/Kit, 6x25T/Kit 8x25T/Kit]CValid to Mar 2029
MDIR-0006511ZYBIO (proGRP Assay CLIA) [50T/Kit, 100T/KitCValid to Mar 2029
MDIR-0006505ZYBIO (Troponin T Assay immunofluroscence) [1x25T/Kit, 2x25T/Kit, 4x25T/Kit, 6x25T/Kit 8x25T/Kit]CValid to Mar 2029
MDIR-0006504ZYBIO (Troponin T/CK-MB/Myoglobin Assay immunofluroscence) [1x25T/Kit, 2x25T/Kit, 4x25T/Kit, 6x25T/Kit, 8x25T/Kit]CValid to Mar 2029
MDIR-0008439Zybio Hemoglobin A1c Assay KitBValid to Apr 2030
MDIE-0002076ZYBIO Blood Culture Bottle (Colorimetric Method) - Resin Anaerobic Bottle (AN) [20 Bottles/box 100…AValid to Jul 2030
MDIE-0002070ZYBIO Chemistry Analyzer [EXC200 EXC220]AValid to Jul 2030
MDIE-0001601Zybio DiluentAValid to Apr 2030
MDIE-0002071ZYBIO Diluent kit [20 Lx1 Bucket, 10 Lx1 bucketAValid to Jul 2030
MDIE-0001603Zybio Hematology AnalyzerAValid to Apr 2030
MDIE-0002072ZYBIO Lyse kit [250mL/ Bottle 500mL/ Bottle]AValid to Jul 2030
MDIE-0002073ZYBIO Lyse kit [Z5 LD) 500mL x 1]AValid to Jul 2030
MDIE-0002074ZYBIO Nucleic Acid Isolation System [EXM3000]AValid to Jul 2030
MDIE-0002075ZYBIO Nucleic Acid Isolation System [EXM6000]AValid to Jul 2030
MDIE-0001602Zybio Probe cleanserAValid to Apr 2030

Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.