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For in vitro diagnostic use. Instrument cobas b 101 IVD cobas® b 101 system INS_2892 06 378 668 243 6 378 668 243 06378668243 6378668243 06378668243 cobas b 101 (HR SL) cobas b 101 system 07613336204375 Instruments Not Available Not Available 06 378 668 170 6 378 668 170 06378668170 6378668170 06378668170 cobas b 101 (FI SV DA NO IS) cobas b 101 system 07613336204368 Instruments Not Available Not Available 06 378 668 016 6 378 668 016 06378668016 6378668016 06378668016 cobas b 101 (DE FR NL IT) cobas b 101 system 07613336204269 Instruments Not Available Not Available 06 378 668 045 6 378 668 045 06378668045 6378668045 06378668045 cobas b 101 (EE LT LV PL) cobas b 101 system 07613336204320 Instruments Not Available Not Available 06 378 668 037 6 378 668 037 06378668037 6378668037 06378668037 cobas b 101 (ES PT) cobas b 101 system 07613336204351 Instruments Not Available Not Available 06 378 668 190 6 378 668 190 06378668190 6378668190 06378668190 cobas b 101 instrument cobas b 101 system 04015630930692 Instruments Not Available Not Available 06 378 668 052 6 378 668 052 06378668052 6378668052 06378668052 cobas b 101 (EL BG) cobas b 101 system 07613336204337 Instruments Not Available Not Available 06 378 668 133 6 378 668 133 06378668133 6378668133 06378668133 cobas b 101 (CZ SK RO HU) cobas b 101 system 07613336204252 Instruments Not Available Not Available The cobas b 101 is an in vitro diagnostic instrument for the quantitative evaluation of clinical chemistry assays and immunoassays using the cobas b 101 test discs. The cobas b 101 instrument is intended for near-patient testing. Not for self-testing. en Sample sizeHbA1c 2 μLLipid19 μLCRP12 μL Sample materialHbA1cCapillary whole blood, venous whole blood with anticoagulant (EDTA or heparin)HbA1c PSTCapillary whole blood LipidsCapillary whole blood, venous whole blood or plasma with anticoagulant (EDTA)Lipid PSTCapillary whole blood CRPCapillary whole blood or serum, venous whole blood or plasma with anticoagulant (EDTA or heparin) Measurement rangeHbA1c20-130 mmol/mol (IFCC) or 4-14 % (DCCT/NGSP) Lipids:CHOL50-500 mg/dL or 1.28-12.95 mmol/LTRIGL45-650 mg/dL or 0.50-7.35 mmol/LHDL-CHOL15-100 mg/dL or 0.38-2.60 mmol/LLDL-CHOLestimated using the Friedewald equation CRP3.0-400 mg/L or 0.30-40.0 mg/dL Test storage2-30°C Test stabilityUnopened:CRP Lipid16 monthsHbA1c22 months Opened20 minutes en
cobas® b 101 system
One-stop solution for HbA1c, lipids, and CRP testing in the Primary Care Setting
One-stop solution for HbA1c, lipids, and CRP testing in the Primary Care Setting
The cobas b 101 system is an IVD test system offering HbA1c, lipid panel and CRP tests at the Point of Care. Fresh capillary blood, K2 or K3-EDTA or lithium heparin anticoagulated venous whole blood can be used for HbA1c. Fresh capillary blood, K2 or K3-EDTA anticoagulated whole blood or plasma can be used for lipids (TC, TG, HDL-TC, LDL, non-HDL). Fresh capillary blood or serum, K2 or K3-EDTA or lithium heparin anticoagulated whole blood or plasma can be used for CRP. The system delivers fast and reliable results and is intended for professional use in a clinical laboratory or at Point of Care locations.
Lipid disc
Direct sample application (no capillaries, tubes or pipettes are needed), requiring only 19 uL of blood.
HbA1c disc
Direct sample application (no capillaries, tubes or pipettes are needed), requiring only 2 uL of blood.
CRP disc
Direct sample application (no capillaries, tubes or pipettes are needed), requiring only 12 uL of blood.
cobas b 101 system complies with all relevant standards and methods (IFCC, DCCT/NGSP)1
Easy and safe operation
User friendly benchtop device
Easy blood sample application onto disc from a finger prick
No calibration needed, maintenance and service-free, guidance by the graphical user interface (GUI)
Fast turnaround time
Single testing with HbA1c, lipid panel and CRP, or dual testing with HbA1c and lipid panel tests
Single test results are available in about 6 minutes (CRP less than 4 minutes) and dual testing results are available after a workflow of under 15 minutes
System characteristics
User-friendly with a large touchscreen, full keyboard, and multiple language support
Robust, maintenance- and calibration-free with a wide operating temperature and humidity range
Connection to cobas® infinity POC IT solutions
External printer or barcode scanner allow an improved workflow and documentation
Data download to USB stick and then to a PC or data download to IT solutions installed on PC
Disc Features
Direct blood sample application onto disc from a finger prick (no capillaries, tubes and pipettes are needed)
Requires only very small sample volumes (2 μL for HbA1c, 19 μL for lipids and 12 μL for CRP)
Discs are color-coded and clearly labelled to support correct use
Hinge cover concept for operator safety
Discs can be stored for more than 16 months at room temperature (2-30 ºC)2,3,4
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References
Roche Multi center evaluation. Data on file (2012)
HbA1c:
Capillary whole blood, venous whole blood with anticoagulant (EDTA or heparin)
HbA1c PST:
Capillary whole blood
Lipids:
Capillary whole blood, venous whole blood or plasma with anticoagulant (EDTA)
Lipid PST:
Capillary whole blood
CRP: Capillary whole blood or serum, venous whole blood or plasma with anticoagulant (EDTA or heparin)
Measurement range
HbA1c:
20-130 mmol/mol (IFCC) or 4-14 % (DCCT/NGSP)
Lipid:
TC: 50-500 mg/dL or 1.28-12.95 mmol/L
TG: 45-650 mg/dL or 0.50-7.35 mmol/L
HDL-TC: 15-100 mg/dL or 0.38-2.60 mmol/L
LDL-TC: estimated using the Friedewald equation
CRP:
3.0-400 mg/L or 0.30-40.0 mg/dL
Test storage
2-30 °C
Shelf life
Unopened:
CRP Lipid: 16 months
HbA1c: 22 months
Opened: 20 minutes
Technical Documents
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