Medical device licence · 99619 · Class 2
ATELLICA CH SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 11, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99619
- Licence holder
- Siemens Healthcare Diagnostics Inc.Newark, DE, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 11, 2017
- Devices covered
- 130
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADVIA CHEMISTRY A1C_E PRETREATMENT SOLUTION
- ATELLICA CH 930 ANALYZER
- ATELLICA CH A-LYTE IMT DILUENT
- ATELLICA CH A-LYTE IMT DILUTION CHECK
- ATELLICA CH A-LYTE IMT STANDARD A
- ATELLICA CH A-LYTE IMT STANDARD B + SALT BRIDGE
- ATELLICA CH A-LYTE INTEGRATED MULTISENSOR
- ATELLICA CH ACETAMINOPHEN
- ATELLICA CH ALANINE AMINOTRANSFERASE (ALT)
- ATELLICA CH ALANINE AMINOTRANSFERASE P5P (ALTPLC)
- ATELLICA CH ALBUMIN
- ATELLICA CH ALBUMIN BCP
- ATELLICA CH ALBUMIN BCP CALIBRATOR
- ATELLICA CH ALKALINE PHOSPHATASE, CONCENTRATED
- ATELLICA CH ALKALINE PHOSPHATASE_2 CALIBRATOR
- ATELLICA CH ALPHA-1-ACID GLYCOPROTEIN
- ATELLICA CH AMMONIA
- ATELLICA CH AMPHETAMINES
- 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 ASPARTATE AMINOTRANSFERASE P5P (ASTPLC)
- ATELLICA CH BARBITURATES (BRB)
- ATELLICA CH BENZODIAZEPINES (BNZ)
- ATELLICA CH BETA2-MICROGLOBULIN
- ATELLICA CH BETA2-MICROGLOBULIN CALIBRATOR
- ATELLICA CH BILIRUBIN CALIBRATOR (BILI CAL)
- ATELLICA CH CALCIUM
- ATELLICA CH CALCIUM_2 (CA_2)
- ATELLICA CH CANNABINOIDS THC (THC)
- ATELLICA CH CARBAMAZEPINE
- ATELLICA CH CARBON DIOXIDE, CONCENTRATED
- ATELLICA CH CHEM CAL
- ATELLICA CH CHEM III CALIBRATOR
- ATELLICA CH CHOLESTEROL 2
- ATELLICA CH CHOLINESTERASE _2 (CHE_2)
- ATELLICA CH CO2 CALIBRATOR/DILUENT
- ATELLICA CH COCAINE METABOLITE (COC)
- ATELLICA CH COMPLEMENT C3
- ATELLICA CH COMPLEMENT C4
- ATELLICA CH CREATINE KINASE
- ATELLICA CH CREATININE 3
- ATELLICA CH CREATININE_2
- ATELLICA CH CYSTATIN C_2 (CYSC_2)
- ATELLICA CH CYSTATIN C_2 CALIBRATORS (CYSC_2 CAL)
- ATELLICA CH DIAZO DIRECT BILIRUBIN (D_DBIL)
- ATELLICA CH DIAZO TOTAL BILIRUBIN (D_TBIL)
- ATELLICA CH DIGOXIN
- ATELLICA CH DIRECT BILIRUBIN 2
- ATELLICA CH DRUG CAL
- ATELLICA CH DRUG CAL II
- ATELLICA CH ECRE3 ENZYMATIC CREATINE_3
- ATELLICA CH ECSTASY (XTC)
- ATELLICA CH ENZ 1 CALIBRATOR
- ATELLICA CH ENZ 2 CALIBRATOR (ENZ 2 CAL)
- ATELLICA CH ENZ 3 CALIBRATOR
- 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 GLUCOSE HEXOKINASE_3
- ATELLICA CH GLUCOSE OXIDASE
- ATELLICA CH HAPTOGLOBIN 2 (HAPT_2)
- ATELLICA CH HDL CHOLESTEROL
- ATELLICA CH HDLC CAL
- ATELLICA CH HIGH SENSITIVITY C-REACTIVE PROTEIN
- ATELLICA CH HIGH SENSITIVITY C-REACTIVE PROTEIN 2 (HCRP2)
- ATELLICA CH HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
- ATELLICA CH IMMUNOGLOBULIN A_2
- ATELLICA CH IMMUNOGLOBULIN G_2
- ATELLICA CH IMMUNOGLOBULIN M_2
- ATELLICA CH 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
- ATELLICA CH LITHIUM_2 (LITH_2)
- ATELLICA CH MAGNESIUM
- ATELLICA CH METHADONE
- ATELLICA CH MICROALBUMIN 2
- ATELLICA CH MICROALBUMIN_2 CALIBRATOR
- ATELLICA CH N-ACETYLPROCAINAMIDE (NAPA)
- ATELLICA CH OPIATES (OP)
- ATELLICA CH OXYCODONE (OXY) ASSAY
- ATELLICA CH PANCREATIC AMYLASE_2 (PAMY_2)
- ATELLICA CH PHENCYCLIDIN
- ATELLICA CH PHENOBARBITAL (PHNB)
- ATELLICA CH PHENYTOIN
- ATELLICA CH PREALBUMIN (PALB)
- ATELLICA CH PROCAINAMIDE (PROC)
- ATELLICA CH PROPOXYPHENE
- 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 TDM CALIBRATORS
- ATELLICA CH THEOPHYLLINE
- ATELLICA CH TOBRAMYCIN
- ATELLICA CH TOTAL BILIRUBIN_2
- ATELLICA CH TOTAL IRON BINDING CAPACITY
- ATELLICA CH TOTAL PROTEIN 2
- ATELLICA CH TOXICOLOGY CALIBRATOR
- ATELLICA CH TRANSFERRIN
- 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 CH ALPHA-1-ANTITRYPSIN 2 (AAT2)
- ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.