Medical device licence · 99897 · Class 2
ATELLICA IM SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 25, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99897
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 25, 2017
- Devices covered
- 127
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ATELLICA IM ERYTHROPOIETIN (EPO) ASSAY
- ATELLICA IM ERYTHROPOIETIN QUALITY CONTROL (EPO QC)
- ATELLICA IM (CPS CAL)
- ATELLICA IM (CPS MCM)
- ATELLICA IM (CPS)
- ATELLICA IM (IL6 QC)
- ATELLICA IM (IL6)
- ATELLICA IM (IRI CAL)
- ATELLICA IM (IRI MCM)
- ATELLICA IM (IRI)
- ATELLICA IM 1300 ANALYZER
- ATELLICA IM 1600 ANALYZER
- ATELLICA IM ACTIVE-B12 (HOLOTRANSCOBALAMIN) (AB12) ASSAY
- ATELLICA IM ACTIVE-B12 MASTER CURVE MATERIAL (AB12 MCM)
- ATELLICA IM ACTIVE-B12 QUALITY CONTROL (AB12 QC)
- ATELLICA IM AMH MASTER CURVE MATERIAL (AMH MCM)
- ATELLICA IM AMH QUALITY CONTROL (AMH QC)
- ATELLICA IM ANDROSTENEDIONE
- ATELLICA IM ANDROSTENEDIONE MASTER CURVE MATERIAL
- ATELLICA IM ANTI-CCP IGG (ACCP) ASSAY
- ATELLICA IM ANTI-CCP IGG MASTER CURVE MATERIAL (ACCP MCM)
- ATELLICA IM ANTI-CCP IGG QUALITY CONTROL (ACCP QC)
- ATELLICA IM ANTI-MÜLLERIAN HORMONE (AMH)
- ATELLICA IM ANTI-THYROGLOBULIN (ATG)
- ATELLICA IM ANTI-THYROGLOBULIN DILUENT
- ATELLICA IM ANTI-THYROGLOBULIN MASTER CURVE MATERIAL (ATG MCM)
- ATELLICA IM ANTI-THYROGLOBULIN QUALITY CONTROL (ATG QC)
- ATELLICA IM ANTI-THYROID PEROXIDASE (ATPO)
- ATELLICA IM ANTI-THYROID PEROXIDASE DILUENT
- ATELLICA IM ANTI-THYROID PEROXIDASE MASTER CURVE MATERIAL (ATPO MCM)
- ATELLICA IM ANTI-THYROID PEROXIDASE QUALITY CONTROL (ATPO QC)
- ATELLICA IM BRAHMS PROCALCITONIN (PCT)
- ATELLICA IM BRAHMS PROCALCITONIN MASTER CURVE MATERIAL (PCT MCM)
- ATELLICA IM BRAHMS PROCALCITONIN QUALITY CONTROL (PCT QC)
- ATELLICA IM CALCITONIN (CALCT)
- ATELLICA IM CALIBRATOR
- ATELLICA IM CORTISOL (COR)
- ATELLICA IM CORTISOL MASTER CURVE MATERIAL (COR MCM)
- ATELLICA IM CORTISOL URINE RECONSTITUTION BUFFER
- ATELLICA IM DHEA-SO4 (DHEAS)
- ATELLICA IM DHEA-SO4 MASTER CURVE MATERIAL (DHEAS MCM)
- ATELLICA IM DHEAS2
- ATELLICA IM DHEAS2 MASTER CURVE MATERIAL (DHEAS2 MCM)
- ATELLICA IM DIGOXIN (DIG)
- ATELLICA IM DIGOXIN MASTER CURVE MATERIAL (DIG MCM)
- ATELLICA IM ELF MASTER CURVE MATERIAL (ELF MCM)
- ATELLICA IM ENHANCED ESTRADIOL (EE2)
- ATELLICA IM ENHANCED ESTRADIOL DILUENT
- ATELLICA IM ENHANCED ESTRADIOL MASTER CURVE MATERIAL (EE2 MCM)
- ATELLICA IM ENHANCED LIVER
- ATELLICA IM ENHANCED LIVER FIBROSIS CALIBRATOR (ELF CAL)
- ATELLICA IM ENHANCED LIVER FIBROSIS QUALITY CONTROL (ELF QC)
- ATELLICA IM FERRITIN (FER MCM)
- ATELLICA IM FERRITIN (FER)
- ATELLICA IM FOLATE (FOL)
- ATELLICA IM FOLATE DILUENT
- ATELLICA IM FOLATE DTT/RELEASING AGENT
- ATELLICA IM FOLATE MASTER CURVE MATERIAL (FOL MCM)
- ATELLICA IM FOLLICLE STIMULATING HORMONE (FSH)
- ATELLICA IM FOLLICLE STIMULATING HORMONE MASTER CURVE MATERIAL (FSH MCM)
- ATELLICA IM FREE THYROXINE (FT4)
- ATELLICA IM FREE THYROXINE MASTER CURVE MATERIAL (FT4 MCM)
- ATELLICA IM FREE TRIIODOTHYRONINE (FT3)
- ATELLICA IM FREE TRIIODOTHYRONINE MASTER CURVE MATERIAL (FT3 MCM)
- ATELLICA IM HEPATITIS A IGM (AHAVM)
- ATELLICA IM HEPATITIS A IGM QUALITY CONTROL (AHAVM QC)
- ATELLICA IM HEPATITIS A TOTAL (AHAVT)
- ATELLICA IM HEPATITIS A TOTAL QUALITY CONTROL (AHAVT QC)
- ATELLICA IM HERPES-1 IGG (HSV1)
- ATELLICA IM HERPES-1 IGG QUALITY CONTROL (HSV1 QC)
- ATELLICA IM HOMOCYSTEINE (HCY)
- ATELLICA IM HOMOCYSTEINE CALIBRATOR (HCY CAL)
- ATELLICA IM HOMOCYSTEINE DILUENT
- ATELLICA IM HOMOCYSTEINE MASTER CURVE MATERIAL (HCY MCM)
- ATELLICA IM HYALURONIC ACID (HA)
- ATELLICA IM INTACT PARATHYROID HORMONE (PTH)
- ATELLICA IM INTACT PARATHYROID HORMONE MASTER CURVE MATERIAL (PTH MCM)
- ATELLICA IM INTACT PARATHYROID HORMONE QUALITY CONTROL (PTH QC)
- ATELLICA IM IRI DIL
- ATELLICA IM LIPOPOLYSACCHARIDE BINDING PROTEIN (LBP)
- ATELLICA IM LIPOPOLYSACCHARIDE BINDING PROTEIN QUALITY CONTROL (LBP QC)
- ATELLICA IM LUTEINIZING HORMONE (LH)
- ATELLICA IM LUTEINIZING HORMONE MASTER CURVE MATERIAL (LH MCM)
- ATELLICA IM N-TERMINAL PROPEPTIDE OF TYPE III PROCOLLAGEN (PIIINP)
- ATELLICA IM NEUROFILAMENT LIGHT CHAIN (NFL)
- ATELLICA IM NFL DILUENT (NFL DIL)
- ATELLICA IM NFL QUALITY CONTROL (NFL QC)
- ATELLICA IM PROGESTERONE (PRGE)
- ATELLICA IM PROGESTERONE MASTER CURVE MATERIAL (PRGE MCM)
- ATELLICA IM PROLACTIN (PRL)
- ATELLICA IM PROLACTIN MASTER CURVE MATERIAL (PRL MCM)
- ATELLICA IM RBC FOLATE ASCORBIC ACID/ASCORBIC ACID DILUENT
- ATELLICA IM SEX HORMONE BINDING GLOBULIN (SHBG)
- ATELLICA IM SEX HORMONE BINDING GLOBULIN CALIBRATOR (SHBG CAL)
- ATELLICA IM SEX HORMONE BINDING GLOBULIN MASTER CURVE MATERIAL (SHBG MCM)
- ATELLICA IM T3/T4/VB12 ANCILLARY REAGENT
- ATELLICA IM TESTOSTERONE II (TSTII)
- ATELLICA IM TESTOSTERONE II MASTER CURVE MATERIAL (TSTII MCM)
- ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL)
- ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA MASTER CURVE MATERIAL (TSH3-UL MCM)
- ATELLICA IM THYROID UPTAKE (TUP)
- ATELLICA IM TISSUE INHIBITOR OF MATRIX METALLOPROTEINASE 1 (TIMP-1)
- ATELLICA IM TOTAL HCG (THCG)
- ATELLICA IM TOTAL HCG DILUENT
- ATELLICA IM TOTAL HCG MASTER CURVE MATERIAL (THCG MCM)
- ATELLICA IM TOTAL IGE (TIGE)
- ATELLICA IM TOTAL IGE DILUENT
- ATELLICA IM TOTAL IGE MASTER CURVE MATERIAL (TIGE MCM)
- ATELLICA IM TOTAL THYROXINE (T4)
- ATELLICA IM TOTAL THYROXINE DILUENT (T4 DIL)
- ATELLICA IM TOTAL THYROXINE MASTER CURVE MATERIAL (T4 MCM)
- ATELLICA IM TOTAL TRIIODOTHYRONINE (T3)
- ATELLICA IM TOTAL TRIIODOTHYRONINE DILUENT
- ATELLICA IM TRIIODOTHYRONINE MASTER CURVE MATERIAL (T3 MCM)
- ATELLICA IM TSH3-ULTRA II (TSH3ULII)
- ATELLICA IM TSH3ULII MASTER CURVE MATERIAL (TSH3ULII MCM)
- ATELLICA IM VITAMIN B12 (VB12)
- ATELLICA IM VITAMIN B12 DILUENT
- ATELLICA IM VITAMIN B12 DTT/RELEASING AGENT
- ATELLICA IM VITAMIN B12 MASTER CURVE MATERIAL (VB12 MCM)
- ATELLICA IM VITAMIN D TOTAL (VITD)
- ATELLICA IM VITAMIN D TOTAL DILUENT
- ATELLICA IM VITAMIN D TOTAL MASTER CURVE MATERIAL (VITD MCM)
- ATELLICA IM VITAMIN D TOTAL QUALITY CONTROL (VITD QC)
- ATELLICA IM VITAMIN D TOTAL II (VITDII)
- ATELLICA IM VITDII DILUENT (VITDII DIL)
- ATELLICA IM VITDII QUALITY CONTROL (VITDII QC)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.