ApprovalTrail

Medical device licence · 108758 · Class 2

ATELLICA CI SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed January 11, 2023. It is in Health Canada’s list of active licences.
Licence number
108758
Licence holder
Siemens Healthcare Diagnostics Inc.Newark, DE, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
January 11, 2023
Devices covered
238

Devices on this licence

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

  • ATELLICA CH ASTPLC ASPARTATE AMINOTRANSFERASE
  • ATELLICA CH A-LYTE IMT DILUENT
  • ATELLICA CH A-LYTE IMT DILUTION CHECK
  • ATELLICA CH A-LYTE IMT NA K CL
  • ATELLICA CH A-LYTE IMT STANDARD A
  • ATELLICA CH A-LYTE IMT STANDARD B + SALT BRIDGE
  • ATELLICA CH ACETAMINOPHEN
  • ATELLICA CH ALB ABLUMIN
  • ATELLICA CH ALBP ALBUMIN
  • ATELLICA CH ALBP CAL
  • ATELLICA CH ALKALINE PHOSPHATASE, CONCENTRATED
  • ATELLICA CH ALKALINE PHOSPHATASE_2 CALIBRATOR
  • ATELLICA CH ALPHA-1-ACID GLYCOPROTEIN
  • ATELLICA CH ALT ALANINE AMINOTRANSFERASE
  • ATELLICA CH ALTPLC ALANINE AMINOTRANSFERASE
  • ATELLICA CH AMMONIA (AMM)
  • ATELLICA CH AMPHETAMINES (AMP)
  • ATELLICA CH AMYLASE_2 (AMY_2)
  • ATELLICA CH ANTI-STREPTOLYSIN-O_3 (ASO_3)
  • ATELLICA CH APOLIPOPROTEIN A-1
  • ATELLICA CH APOLIPOPROTEIN A-1 & B CALIBRATOR
  • ATELLICA CH APOLIPOPROTEIN B
  • ATELLICA CH ASPARTATE AMINOTRANSFERASE (AST)
  • ATELLICA CH BARBITURATES (BRB)
  • ATELLICA CH BENZODIAZEPINES (BNZ)
  • ATELLICA CH BETA2-MICROGLOBULIN
  • ATELLICA CH BETA2-MICROGLOBULIN CALIBRATOR
  • ATELLICA CH BILIRUBIN CALIBRATOR
  • ATELLICA CH CALCIUM
  • ATELLICA CH CALCIUM_2 (CA_2)
  • ATELLICA CH CANNABINOIDS THC (THC)
  • ATELLICA CH CANNABINOIDS THC (THCC)
  • ATELLICA CH CARBAMAZEPINE
  • ATELLICA CH CARBON DIOXIDE, CONCENTRATED
  • ATELLICA CH CHEM CAL CHEMISTRY
  • ATELLICA CH CHEM III CALIBRATOR (CHEM III CAL)
  • ATELLICA CH CHOLESTEROL 2
  • ATELLICA CH CHOLINESTERASE _2 (CHE_2)
  • ATELLICA CH CK_L CREATINE KINASE
  • ATELLICA CH CO2 CALIBRATOR/DILUENT
  • ATELLICA CH COCAINE METABOLITE (COC)
  • ATELLICA CH COMPLEMENT C3 (C3)
  • ATELLICA CH COMPLEMENT C4 (C4)
  • ATELLICA CH CREATININE 3
  • ATELLICA CH CREA_2 CREATININE
  • ATELLICA CH DBIL_2 DIRECT BILIRUBIN
  • ATELLICA CH DIAZO DIRECT BILIRUBIN (D_DBIL)
  • ATELLICA CH DIAZO TOTAL BILIRUBIN (D_TBIL)
  • ATELLICA CH DRUG CAL (DRUG CAL)
  • ATELLICA CH DRUG CAL II
  • ATELLICA CH ECSTASY (XTC)
  • ATELLICA CH ENZ 1 CALIBRATOR
  • ATELLICA CH ENZ 2 CAL
  • ATELLICA CH ENZ 3 CAL
  • ATELLICA CH ENZYMATIC CREATININE_3 (ECRE3)
  • ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E) ASSAY
  • ATELLICA CH ENZYMATIC HEMOGLOBIN A1C_E CALIBRATOR (A1C_E CAL)
  • ATELLICA CH ETHYL ALCOHOL
  • ATELLICA CH FRUCTOSAMINE (FRUC)
  • ATELLICA CH FRUCTOSAMINE CALIBRATOR (FRUC CAL)
  • ATELLICA CH GAMMAGLUTAMYL TRANSFERASE_2 (GGT_2)
  • ATELLICA CH GENTAMICIN
  • ATELLICA CH GLUH_3 GLUCLOSE
  • ATELLICA CH GLUO GLUCOSE
  • ATELLICA CH HAPTOGLOBIN 2 (HAPT_2)
  • ATELLICA CH HDL CHOLESTEROL
  • ATELLICA CH HDLC CAL
  • ATELLICA CH HIGH SENSITIVITY C-REACTIVE PROTEIN 2 (HCRP2)
  • ATELLICA CH IMMUNOGLOBULIN A_2
  • ATELLICA CH IMMUNOGLOBULIN G_2
  • ATELLICA CH IMMUNOGLOBULIN M_2
  • ATELLICA CH IP INORGANIC PHOSPHORUS
  • ATELLICA CH IRON3 (IRON3)
  • ATELLICA CH IRON_2
  • ATELLICA CH LACTATE DEHYDROGENASE L-P
  • ATELLICA CH LACTATE_3 (LAC_3)
  • ATELLICA CH LDLC CAL
  • ATELLICA CH LDLC LDL CHOLESTEROL
  • ATELLICA CH LIDOCAINE (LIDO)
  • ATELLICA CH LIPASE
  • ATELLICA CH LIPOPROTEIN
  • ATELLICA CH LIPOPROTEIN(A) CALIBRATOR
  • ATELLICA CH LIQUID SPECIFIC PROTEIN CALIBRATORS (LSP CAL)
  • ATELLICA CH LITHIUM_2 (LITH_2)
  • ATELLICA CH MAGNESIUM
  • ATELLICA CH METHADONE (MDN)
  • ATELLICA CH MICROALBUMIN_2 (ΜALB_2)
  • ATELLICA CH MICROALBUMIN_2 CALIBRATOR (MICRO ALB_2 CAL)
  • ATELLICA CH N-ACETYLPROCAINAMIDE (NAPA)
  • ATELLICA CH OPIATES (OP)
  • ATELLICA CH OXYCODONE (OXY)
  • ATELLICA CH PANCREATIC AMYLASE_2 (PAMY_2)
  • ATELLICA CH PHENCYCLIDINE (PCP)
  • ATELLICA CH PHENOBARBITAL (PHNB)
  • ATELLICA CH PHENYTOIN (PHNY)
  • ATELLICA CH PREALBUMIN (PALB)
  • ATELLICA CH PROCAINAMIDE (PROC)
  • ATELLICA CH PROPOXYPHENE (PPX)
  • ATELLICA CH PROTEIN 1 CALIBRATOR (PROT1 CAL)
  • ATELLICA CH PROTEIN 2 CALIBRATOR (PROT2 CAL)
  • ATELLICA CH REVISED C-REACTIVE PROTEIN (RCRP)
  • ATELLICA CH REVISED C-REACTIVE PROTEIN CALIBRATOR (RCRP CAL)
  • ATELLICA CH RHEUMATOID FACTOR
  • ATELLICA CH SALICYLATE
  • ATELLICA CH SPECIAL CHEMISTRY CALIBRATOR
  • ATELLICA CH TBIL_2 TOTAL BILIRUBIN
  • ATELLICA CH THEOPHYLLINE (THEO)
  • ATELLICA CH TOBRAMYCIN
  • ATELLICA CH TOTAL IRON BINDING CAPACITY
  • ATELLICA CH TOTAL PROTEIN 2
  • ATELLICA CH TOXICOLOGY CALIBRATOR
  • ATELLICA CH TRANSFERRIN (TRF)
  • ATELLICA CH TRIG 2 TRIGLYCERIDES
  • ATELLICA CH UREA NITROGEN
  • ATELLICA CH URIC ACID
  • ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)
  • ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN CALIBRATOR (UCFP CAL)
  • ATELLICA CH URINE ALBUMIN (UALB)
  • ATELLICA CH URINE ALBUMIN CALIBRATOR (UALB CAL)
  • ATELLICA CH VALPROIC ACID
  • ATELLICA CH VANCOMYCIN
  • ATELLICA CI
  • ATELLICA IM (CPS CAL)
  • ATELLICA IM (CPS MCM)
  • ATELLICA IM (CPS)
  • ATELLICA IM (IRI CAL)
  • ATELLICA IM (IRI MCM)
  • ATELLICA IM (IRI)
  • ATELLICA IM AMH MASTER CURVE MATERIAL (AMH MCM)
  • ATELLICA IM AMH QUALITY CONTROL (AMH QC)
  • ATELLICA IM ANTI-MÜLLERIAN HORMONE (AMH)
  • 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 CALIBRATOR
  • ATELLICA IM CALIBRATOR C (CAL C)
  • ATELLICA IM CALIBRATOR E (CAL E)
  • 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 FIBROSIS (ELF)
  • 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 HOMOCYSTEINE (HCY)
  • ATELLICA IM HOMOCYSTEINE CALIBRATOR (HCY CAL)
  • ATELLICA IM HOMOCYSTEINE DILUENT
  • 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 LUTEINIZING HORMONE (LH)
  • ATELLICA IM LUTEINIZING HORMONE MASTER CURVE MATERIAL (LH MCM)
  • 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 (T3/T4/VB12 ANC)
  • ATELLICA IM TESTOSTERONE II (TSTII)
  • ATELLICA IM TESTOSTERONE II MASTER CURVE MATERIAL (TSTII MCM)
  • ATELLICA IM THCG DIL
  • ATELLICA IM THCG MCM
  • ATELLICA IM THCG+B TOTAL HCG
  • ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA (TSH3-UL)
  • ATELLICA IM THYROID STIMULATING HORMONE 3-ULTRA MASTER CURVE MATERIAL (TSH3-UL 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 (VB12 DIL)
  • ATELLICA IM VITAMIN B12 DTT/ RELEASING AGENT (VB12 DTT/REL)
  • ATELLICA IM VITAMIN B12 MASTER CURVE MATERIAL (VB12 MCM)
  • ATELLICA IM VITAMIN D TOTAL (VITD)
  • ATELLICA IM VITAMIN D TOTAL DILUENT (VITD DIL)
  • ATELLICA IM VITAMIN D TOTAL MASTER CURVE MATERIAL (VITD MCM)
  • ATELLICA IM VITAMIN D TOTAL QUALITY CONTROL (VITD QC)
  • ATELLICA RACK HANDLER
  • ATELLICA CH A1C_EZ PRE
  • ATELLICA CH ACETAMINOPHEN (ACETC)
  • ATELLICA CH ACETAMINOPHEN 2 (ACTM)
  • ATELLICA CH ACETAMINOPHEN 2 (ACTMC)
  • ATELLICA CH ALPHA-1-ANTITRYPSIN 2 (AAT2)
  • ATELLICA CH AMPHETAMINES (AMPC)
  • ATELLICA CH BARBITURATES (BRBC)
  • ATELLICA CH BENZODIAZEPINES (BNZC)
  • ATELLICA CH COCAINE METABOLITE (COCC)
  • ATELLICA CH ECSTASY (XTCC)
  • ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E)
  • ATELLICA CH ETHYL ALCOHOL (ETOHC)
  • ATELLICA CH METHADONE (MDNC)
  • ATELLICA CH OPIATES (OPC)
  • ATELLICA CH OXYCODONE (OXYC)
  • ATELLICA CH PHENCYCLIDINE (PCPC)
  • ATELLICA CH SALICYLATE (SALC)
  • ATELLICA IM VITAMIN D TOTAL II (VITDII)
  • ATELLICA IM VITDII DILUENT (VITDII DIL)
  • ATELLICA IM VITDII QUALITY CONTROL (VITDII QC)
  • CALIBRATOR B (CAL B)

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