ApprovalTrail

Medical device licence · 10355 · Class 2

SYNCHRON SYSTEMS

Yes: licensed in Canada

Licence status Issued (active); first licensed August 23, 1999. It is in Health Canada’s list of active licences.
Licence number
10355
Licence holder
Beckman Coulter, Inc.San Diego, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
August 23, 1999
Devices covered
92

Devices on this licence

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

  • CHOLINESTERASE REAGENT (CHE)
  • SHYNCHRON SYSTEMS IG-G REAGENT
  • SYCHRON SYSTEMS AMMONIA (AMM) REAGENT
  • SYNCHRON CX SYSTEMS HDL CHOLESTEROL (HDLC) REAGENT
  • SYNCHRON CX SYSTEMS IMMUNOGLOBULIN A REAGENT (IGA)
  • SYNCHRON CX SYSTEMS IMMUNOGLOBULIN G REAGENT (IGG)
  • SYNCHRON CX SYSTEMS IMMUNOGLOBULIN M REAGENT (IGM)
  • SYNCHRON CX SYSTEMS ISE ELECTROLYTE BUFFER
  • SYNCHRON CX SYSTEMS TRANSFERRIN REAGENT (TRF)
  • SYNCHRON CX T-UPTAKE REAGENT KIT
  • SYNCHRON CX3 CLINICAL SYSTEM ANALYZER - CLASS 2
  • SYNCHRON CX4 SYSTEM ANALYZER - CLASS 2
  • SYNCHRON CX5 SYSTEM ANALYZER - CLASS 2
  • SYNCHRON CX7 SYSTEM ANALYZER - CLASS 2
  • SYNCHRON CX9 ALX SYSTEM ANALYZER - CLASS 2
  • SYNCHRON LX20 SYSTEM ANALYZER - CLASS 2
  • SYNCHRON SYSTEM CALCIUM REAGENTS(CA)
  • SYNCHRON SYSTEMS ACETAMINOPHEN REAGENT
  • SYNCHRON SYSTEMS ALBUMIN (ALBM) REAGENT
  • SYNCHRON SYSTEMS ALBUMIN REAGENT (ALB)
  • SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT (ALP)
  • SYNCHRON SYSTEMS ALT REAGENT
  • SYNCHRON SYSTEMS AMPHETAMINE REAGENT
  • SYNCHRON SYSTEMS AMPHETAMINE REAGENT
  • SYNCHRON SYSTEMS AMYLASE REAGENT (AMY)
  • SYNCHRON SYSTEMS ANTISTREPTOLYSIN-O (ASO) REAGENT
  • SYNCHRON SYSTEMS APO-B REAGENT
  • SYNCHRON SYSTEMS APOA REAGENT
  • SYNCHRON SYSTEMS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
  • SYNCHRON SYSTEMS BARBITURATES REAGENT
  • SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
  • SYNCHRON SYSTEMS C-REACTIVE PROTEIN REAGENT (CRP)
  • SYNCHRON SYSTEMS CANNABINOID (THC) REAGENT
  • SYNCHRON SYSTEMS CARBAMAZEPINE (CAR) REAGENT
  • SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
  • SYNCHRON SYSTEMS COCAINE REAGENT
  • SYNCHRON SYSTEMS COMPLEMENT C3 (C3)
  • SYNCHRON SYSTEMS COMPLEMENT C4 (C4)
  • SYNCHRON SYSTEMS CREATINE KINASE REAGENT (CK)
  • SYNCHRON SYSTEMS CREATININE REAGENT
  • SYNCHRON SYSTEMS CREATININE REAGENT (CRE)
  • SYNCHRON SYSTEMS DIGOXIN (DIG) REAGENT
  • SYNCHRON SYSTEMS DIRECT BILIRUBIN REAGENT (DBIL)
  • SYNCHRON SYSTEMS DIRECT LDL CHOLESTEROL REAGENT
  • SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT
  • SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT
  • SYNCHRON SYSTEMS ETHANOL REAGENT
  • SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT
  • SYNCHRON SYSTEMS GAMMA GLUTAMYL TRANSFERASE (GGT) REAGENT
  • SYNCHRON SYSTEMS GENTAMICIN (GEN) REAGENT
  • SYNCHRON SYSTEMS GLUCOSE REAGENT
  • SYNCHRON SYSTEMS GLUCOSE REAGENT (GLU)
  • SYNCHRON SYSTEMS GLUCOSE REAGENT (GLU) OXIDASE
  • SYNCHRON SYSTEMS GLUTAMATE OXALACETATE REAGENT (GOT)
  • SYNCHRON SYSTEMS GLUTAMATE PYRUVATE TRANSAMINASE (GPT) REAGENT
  • SYNCHRON SYSTEMS HAPTOGLOBIN (HPT)
  • SYNCHRON SYSTEMS HDL CHOLESTEROL REAGENT
  • SYNCHRON SYSTEMS HEMOGLOBIN A1C (HBA1C) REAGENT
  • SYNCHRON SYSTEMS IG-A REAGENT
  • SYNCHRON SYSTEMS IG-M REAGENT
  • SYNCHRON SYSTEMS IRON (FE) REAGENT
  • SYNCHRON SYSTEMS LACTATE DEHYDROGENASE REAGENT (LD-L)
  • SYNCHRON SYSTEMS LACTATE REAGENT (LAC)
  • SYNCHRON SYSTEMS LIPASE (LIP) REAGENT
  • SYNCHRON SYSTEMS MAGNESIUM (MG) REAGENT
  • SYNCHRON SYSTEMS METHADONE (METD) REAGENT
  • SYNCHRON SYSTEMS MICROALBUMIN REAGENT
  • SYNCHRON SYSTEMS MICROPROTEIN (M-TP) REAGENT
  • SYNCHRON SYSTEMS OPIATE (OP) REAGENT
  • SYNCHRON SYSTEMS OPIATE 2000 NG REAGENT
  • SYNCHRON SYSTEMS PANCREATIC AMYLASE REAGENT (PAMY)
  • SYNCHRON SYSTEMS PHENCYCLIDINE (PCP) REAGENT
  • SYNCHRON SYSTEMS PHENOBARBITAL (PHE) REAGENT
  • SYNCHRON SYSTEMS PHENYTOIN (PHY) REAGENT
  • SYNCHRON SYSTEMS PHOSPHORUS (PHOSM) REAGENT
  • SYNCHRON SYSTEMS PHOSPHORUS REAGENT (PHOS)
  • SYNCHRON SYSTEMS PREALBUMIN REAGENT
  • SYNCHRON SYSTEMS PROPOXYPHENE (PROX) REAGENT
  • SYNCHRON SYSTEMS SALICYLATE REAGENT
  • SYNCHRON SYSTEMS THEOPHYLLINE (THE) REAGENT
  • SYNCHRON SYSTEMS THYROXINE (T4) REAGENT
  • SYNCHRON SYSTEMS TOBRAMYCIN (TOB) REAGENT
  • SYNCHRON SYSTEMS TOTAL BILIRUBIN REAGENT (TBIL)
  • SYNCHRON SYSTEMS TOTAL IRON BINDING CAPACITY (IBCT) REAGENT
  • SYNCHRON SYSTEMS TOTAL PROTEIN REAGENT
  • SYNCHRON SYSTEMS TRANSFERRIN (TRFN) REAGENT
  • SYNCHRON SYSTEMS TRIGLYCERIDES (TG) REAGENT
  • SYNCHRON SYSTEMS UREA NITROGEN REAGENT
  • SYNCHRON SYSTEMS UREA NITROGEN REAGENT (BUN)
  • SYNCHRON SYSTEMS URIC ACID REAGENT (URIC)
  • SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT
  • SYNCHRON SYSTEMS VANCOMYCIN REAGENT

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