ApprovalTrail

Medical device licence · 100031 · Class 3

ATELLICA IM SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed November 23, 2017. It is in Health Canada’s list of active licences.
Licence number
100031
Licence holder
Siemens Healthcare Diagnostics Inc.Newark, DE, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
November 23, 2017
Devices covered
66

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • ATELLICA IM 1300 ANALYZER
  • ATELLICA IM 1600 ANALYZER
  • ATELLICA IM ALPHA FETOPROTEIN (AFP)
  • ATELLICA IM ALPHA FETOPROTEIN MASTER CURVE MATERIAL (AFP MCM)
  • ATELLICA IM B-TYPE NATRIURETIC PEPTIDE (BNP)
  • ATELLICA IM BR 27.29
  • ATELLICA IM BR 27.29 CALIBRATOR (BR CAL)
  • ATELLICA IM BR 27.29 MASTER CURVE MATERIAL (BR MCM)
  • ATELLICA IM BR PRE
  • ATELLICA IM CA 125II
  • ATELLICA IM CA 125II CALIBRATOR
  • ATELLICA IM CA 125II MCM
  • ATELLICA IM CA 15-3 ASSAY
  • ATELLICA IM CA 15-3 CALIBRATOR
  • ATELLICA IM CA 15-3 MCM (MASTER CURVE MATERIAL)
  • ATELLICA IM CA 19-9
  • ATELLICA IM CA 19-9 DIL
  • ATELLICA IM CA 19-9 MCM
  • ATELLICA IM CALIBRATOR
  • ATELLICA IM CALIBRATOR Q (CAL Q)
  • ATELLICA IM CALIBRATOR Y (CAL Y)
  • ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)
  • ATELLICA IM CARCINOEMBRYONIC MASTER CURVE MATERIAL (CEA MCM)
  • ATELLICA IM CEA DIL (DILUENT)
  • ATELLICA IM COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA)
  • ATELLICA IM COMPLEXED PROSTATE SPECIFIC ANTIGEN MASTER CURVE MATERIAL (CPSA MCM)
  • ATELLICA IM COMPLEXED PROSTATE SPECIFIC ANTIGEN QUALITY CONTROL (CPSA QC)
  • ATELLICA IM CPSA PRE (PRETREATMENT REAGENT)
  • ATELLICA IM CREATINE KINASE MB (CKMB)
  • ATELLICA IM CREATINE KINASE MB CALIBRATOR (CKMB CAL)
  • ATELLICA IM CREATINE KINASE MB DILUENT (CKMB DIL)
  • ATELLICA IM CREATINE KINASE MB MASTER CURVE MATERIAL (CKMB MCM)
  • ATELLICA IM CYCLOSPORINE (CSA)
  • ATELLICA IM CYCLOSPORINE (CSA) CALIBRATOR (CAL)
  • ATELLICA IM CYCLOSPORINE (CSA) MASTER CURVE MATERIAL (MCM)
  • ATELLICA IM CYCLOSPORINE (CSA) PRETREATMENT REAGENT (PRE)
  • ATELLICA IM FPSA
  • ATELLICA IM FPSA CAL
  • ATELLICA IM FREE BETA HUMAN CHORIONIC GONADOTROPIN (FBHCG)
  • ATELLICA IM HER-2/NEU (H2N)
  • ATELLICA IM HER-2/NEU CALIBRATOR (H2N CAL)
  • ATELLICA IM HER-2/NEU MASTER CURVE MATERIAL (H2N MCM)
  • ATELLICA IM HER-2/NEU QUALITY CONTROL (H2N QC)
  • ATELLICA IM HERPES-2 IGG (HSV2)
  • ATELLICA IM HERPES-2 IGG QUALITY CONTROL (HSV2 QC)
  • ATELLICA IM HIGH SENSITIVITY TROPONIN I (TNIH)
  • ATELLICA IM MYOGLOBIN (MYO)
  • ATELLICA IM MYOGLOBIN MASTER CURVE MATERIAL (MYO MCM)
  • ATELLICA IM NT-PROBNP (PBNP)
  • ATELLICA IM NT‑PROBNPII (PBNPII)
  • ATELLICA IM PBNP MASTER CURVE MATERIAL (PBNP MCM)
  • ATELLICA IM PREGNANCY-ASSOCIATED PLASMA PROTEIN-A (PAPP-A)
  • ATELLICA IM PROSTATE SPECIFIC ANTIGEN (PSA)
  • ATELLICA IM PROSTATE SPECIFIC ANTIGEN MASTER CURVE MATERIAL (PSA MCM)
  • ATELLICA IM RUBELLA IGG (RUB G)
  • ATELLICA IM RUBELLA IGG QUALITY CONTROL (RUB G QC)
  • ATELLICA IM RUBELLA IGM (RUB M)
  • ATELLICA IM RUBELLA IGM QUALITY CONTROL (RUB M QC)
  • ATELLICA IM TNIH MCM
  • ATELLICA IM TOXOPLASMA IGG (TOXO G)
  • ATELLICA IM TOXOPLASMA IGG QUALITY CONTROL (TOXO G QC)
  • ATELLICA IM TOXOPLASMA IGM (TOXO M)
  • ATELLICA IM TOXOPLASMA IGM QUALITY CONTROL (TOXO M QC)
  • B-TYPE NATRIURETIC PEPTIDE CALIBRATOR (BNP CAL)
  • B-TYPE NATRIURETIC PEPTIDE MASTER CURVE MATERIAL (BNP MCM)
  • B-TYPE NATRIURETIC PEPTIDE QUALITY CONTROL (BNP QC)

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.