Beckman Coulter System Reagent, AU400/AU400e URINE AMYLASE Cat. No.: OSR6x06 Reagent ID: 006

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1 Beckman Coulter System Reagent, AU400/AU400e Test Name: AMY Type: Urine Operation: Yes Sample: Volume 2 L Dilution 0 L Pre-Dilution Rate: 1 Reagents: R1 Volume 200 L Dilution 0 L Min OD Max OD R2 Volume 0 L Dilution 0 L L -0.1 H 1.5 Reagent OD limit: Wavelength: Pri. 410 Sec. 480 First L -0.1 First H 0.2 Method: RATE Last L -0.1 Last H 0.2 Reaction slope: + Dynamic Range: Measuring First 5 Last 10 L 10* H 1500* Measuring First Last Correlation Factor: Linearity: 15 % A B 0 No Lag Time: NO On-board stability period: 30 Test Name: AMY Type: Urine Value/Flag: # Level L: # Level H: # Normal Ranges: Age L Age H Sex Year Month Year Month L H 1. # # # # # # # 2. # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. None Selected # # 8. Out of Range L H # # Panic Value: # # Unit: U/L* Decimal places: # Test Name: AMY Type Urine Use Serum Cal Calibration Type: MB Formula: Y=AX+B Counts: # Process: Point 3: Point 4: Cal. No. OD CONC Factor/OD-L Factor/OD-H 1-Point Cal. Point: With CONC-0 Slope Check None Advanced Calibration: ## MB Type Factor: 8922* Calibration Stability Period: # User defined ## Lot or Lot + Bottle * Values set for working in U/L. To work in SI units (µkat/l) divide 60 System Factor

2 Beckman Coulter System Reagent, AU640/AU640 e Test Name: AMY Type: Urine Operation: Yes Sample: Volume 2 L Dilution 0 L Pre-Dilution Rate: 1 Reagents: R1 Volume 200 L Dilution 0 L Min OD Max OD R2 Volume 0 L Dilution 0 L L -0.1 H 1.5 Reagent OD limit: Wavelength: Pri. 410 Sec. 480 First L -0.1 First H 0.2 Method: RATE Last L -0.1 Last H 0.2 Reaction slope: + Dynamic Range: Measuring First 5 Last 10 L 10* H 1500* Measuring First Last Correlation Factor: Linearity: 15 % A B 0 No Lag Time: NO On-board stability period: 30 Test Name: AMY Type: Urine Value/Flag: # Level L: # Level H: # Normal Ranges: Age L Age H Sex Year Month Year Month L H 1. # # # # # # # 2. # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. None Selected # # 8. Out of Range L H # # Panic Value: # # Unit: U/L* Decimal places: # Test Name: AMY Type Urine Use Serum Cal Calibration Type: MB Formula: Y=AX+B Counts: # Process: Point 3: Point 4: Cal. No. OD CONC Factor/OD-L Factor/OD-H 1-Point Cal. Point: With CONC-0 Slope Check None Advanced Calibration: ## MB Type Factor: 8922* Calibration Stability Period: # User defined ## Lot or Lot + Bottle * Values set for working in U/L. To work in SI units (µkat/l) divide 60 System Factor

3 , AU480 Beckman Coulter System Reagent: OSR6x06 Test Name: AMY Type: Urine Operation: Yes Sample Volume 1.6 L Dilution 0 L OD Limit Pre-Dilution Rate 1 Min. OD -0.1 Max. OD 1.5 Reagents Volume: R1(R1-1) 160 L Dilution 0 L Reagent OD limit: R2 (R2-1) 0 L Dilution 0 L First Low -0.1 High 0.2 Last Low -0.1 High 0.2 Dynamic Range Low 10* High 1500* Correlation Factor A 1 B 0 Wavelength: Pri. 410 nm Sec. 480 nm Factor for Maker A ψ B 0 Method: RATE Reaction slope: + Onboard Stability 30 Day 0 Hour Measuring First 5 Last 10 Measuring First Last Linearity: 15 % No Lag Time: NO Range Test Name: AMY Type: Urine Value/Flag: VALUE Level L: # Level H: # Specific Ranges: From To Panic Value Sex Year Month Year Month Low High Low High 1. # # # # # # # # # 2. # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. No demographics # # 8. Not within expected values # # Unit U/L* Decimal Places # Test Name: AMY Type Urine Use Serum Cal. Calibration Type: MB Formula: Y=AX+B Counts: # <Calibrator Parameters> Slope Check Calibrator OD Conc Factor Range Low High Allowable Range Check Reagent Blank Calibration Point 3: Advanced Calibration Point 4: Operation Yes Interval (RB/ACAL) Lot / Lot Point 8: Point 9: Point10: <Point Cal. For Master Curve> No. of Correction Points Use Master Curve Lot Calibration Calibrator OD Conc OD Range Stability Low High Reagent Blanks 7 Day 0 Hour Calibration Day Hour MB Type Factor: 8922* 1-Point Calibration Point With CONC-0 # User defined * Values set for working in U/L. To work in SI units (kat/l) divide by 60 ψ System Factor

4 , AU680 Beckman Coulter System Reagent: OSR6x06 Test Name: AMY Type: Urine Operation: Yes Sample Volume 1.6 L Dilution 0 L OD Limit Pre-Dilution Rate 1 Min. OD -0.1 Max. OD 1.5 Reagents Volume: R1(R1-1) 160 L Dilution 0 L Reagent OD limit: R2 (R2-1) 0 L Dilution 0 L First Low -0.1 High 0.2 Last Low -0.1 High 0.2 Dynamic Range Low 10* High 1500* Common Reagent Type None Name Correlation Factor A 1 B 0 Wavelength: Pri. 410 nm Sec. 480 nm Factor for Maker A ψ B 0 Method: RATE Reaction slope: + Onboard Stability 30 Days 0 Hour Measuring First 5 Last 10 Measuring First Last Linearity: 15 % No Lag Time: NO Range Test Name: AMY Type: Urine Value/Flag: VALUE Level L: # Level H: # Specific Ranges: From To Panic Value Sex Year Month Year Month Low High Low High 1. # # # # # # # # # 2. # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. No demographics # # 8. Not within expected values # # Unit U/L* Decimal Places # Test Name: AMY Type Urine Use Serum Cal. Calibration Type: MB Formula: Y=AX+B Counts: # <Calibrator Parameters> Slope Check Calibrator OD Conc Factor Range Low High Allowable Range Check Reagent Blank Calibration Point 3: Advanced Calibration Point 4: Operation Yes Interval (RB/ACAL) Lot / Lot Point 8: Point 9: Point10: <Point Cal. For Master Curve> No. of Correction Points Use Master Curve Lot Calibration Calibrator OD Conc OD Range Stability Low High Reagent Blanks 7 Day 0 Hour Calibration Day Hour MB Type Factor: 8922* 1-Point Calibration Point With CONC-0 # User defined * Values set for working in U/L. To work in SI units (kat/l) divide by 60 ψ System Factor

5 Beckman Coulter System Reagent, AU600 Specific test parameters Test No # Test name AMY Sample type Urine Page 1/2 Sample vol. 2 Dil. vol 0 l Min. OD Max. OD Reagent 1 vol 200 Dil. vol 0 l L H Reagent 2 vol 0 Dil. vol 0 l Reagent OD limit Fst. L Fst. H Wave Main 410 Sub 480 Lst. L Lst. H Method RATE Dynamic range Reaction + L 10* H 1500* Point 1 Fst 5 Lst 10 Correlation factor A 1 Point 2 Fst Lst B 0 Linearity Fst 15 % Sec % No lag time NO On-board stability period 30 Select using Space key, or select from list displayed by Guide key Test No # Test name AMY Sample type Urine Page 2/2 Level L Level H Value/flag # # # Normal range Sex Age L Age H L H 1 # # Y # M # Y # M # # 2 # # Y # M # Y # M # # 3 # # Y # M # Y # M # # 4 # # Y # M # Y # M # # 5 # # Y # M # Y # M # # 6 # # Y # M # Y # M # # 7 Non select # # 8 Out of range # # L H Panic value # # Select the function using the Function key or the Mouse Calibration specific Test No # Name AMY Cal type 1 MB Count # Formula 1 Y=AX+B Process Selection calibrator Cal No OD Conc Factor/OD-L Factor/OD-H Point 1 Point 2 Point 3 Point 4 Point 5 Point 6 Point 7 1-point cal. point MB type factor 8922* Calibrator stability period Select the function using the Function key or the Mouse # To be inserted by the user * Values set for working in U/L. To work in SI units (µkat/l) divide by 60

6 Beckman Coulter System Reagent, AU2700/AU5400 Test Name: AMY Type: Urine Operation: Yes Sample: Volume 1.6 L Dilution 0 L Pre-Dilution Rate: 1 Reagents: R1 Volume 160 L Dilution 0 L Min OD Max OD R2 Volume 0 L Dilution 0 L L -0.1 H 1.5 Reagent OD limit: Wavelength: Pri. 410 Sec. 480 First L -0.1 First H 0.2 Method: RATE Last L -0.1 Last H 0.2 Reaction slope: + Dynamic Range: Measuring First 5 Last 10 L 10* H 1500* Measuring First Last Correlation Factor: Linearity: 15 % A 1 B 0 No Lag Time: NO On-board stability period: 30 Test Name: AMY Type: Urine Value/Flag: # Level L: # Level H: # Normal Ranges: Age L Age H Sex Year Month Year Month L H 1. # # # # # # # 2. # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. None Selected # # 8. Out of Range L H # # Panic Value: # # Unit: U/L* Decimal places: # Test Name: AMY Type Urine Use Serum Cal Calibration Type: MB Formula: Y=AX+B Counts: # Process: Point 3: Point 4: Cal. No. OD CONC Factor/OD-L Factor/OD-H 1-Point Cal. Point: With CONC-0 Slope Check None Advanced Calibration: ## MB Type Factor: * Calibration Stability Period: # User defined ## Lot or Lot + Bottle * Values set for working in U/L. To work in SI units (kat/l) divide by 60 Instrument MB Factor- Set by Beckman Coulter, specific for each instrument cuvette wheel.

7 , AU5800 Beckman Coulter System Reagent: OSR6x06 Parameters General LIH ISE HbA1c Calculated Test Range Test Name: AMY Type: Urine Operation: Yes Sample Volume 1.2 L Dilution 0 L OD Limit Pre-Dilution Rate 1 Diluent Bottle # Min. OD -0.1 Max. OD 1.5 Reagents Volume: R1(R1-1) 120 L Dilution 0 L Reagent OD limit: R1-2 L Dilution L First Low -0.1 High 0.2 R2 (R2-1) 0 L Dilution 0 L Last Low -0.1 High 0.2 Dynamic Range Low 10* High 1500* Common Rgt. Type None Name None Correlation Factor A 1 B 0 Wavelength: Pri. 410 nm Sec. 480 nm Factor for Maker A 1 B 0 Method: RATE Reaction slope: + Onboard Stability 30 Day 0 Hour Measuring First 5 Last 10 Measuring First Last Linearity Limit: 15 % Lag Time Check: NO Parameters General LIH ISE HbA1c Calculated Test Range Test Name: AMY Type: Urine Value/Flag: # Level Low # High # Specific Ranges: From To Sex Year Month Year Month Low High 1. # # # # # # # 2. # # # # # # # 3. # # # # # # # 4. # # # # # # # 5. # # # # # # # 6. # # # # # # # 7. Standard demographics # # 8. Not within expected values # # Panic Value Low # High # Unit U/L* Decimal Places # Parameters Calibrators Calibration Parameters Test Name: AMY Type Urine Cuvette Use Serum Cal. Calibration Type: MB Formula: Y=AX+B Counts: # <Calibrator Parameters> Slope Check None Calibrator OD Conc Factor Range Low High Allowable Range Check Point 3: Reagent Blank Point 4: Calibration Advanced Calibration Operation Yes Point 8: Interval (RB/ACAL) Lot/Lot Point 9: Point10: Lot Calibration <Point Cal. For Master Curve> No. of Correction Points Use Master Curve Calibrator OD Conc OD Range Stability Low High Reagent Blank Day Hour Calibration Day Hour MB Type Factor: 1-Point Calibration Point With Conc-0 # User Defined * Values set for working in U/L. To work in SI units (kat/l) divide by 60 Instrument MB factor set by engineer, specific for each instrument cuvette wheel

Beckman Coulter System Reagent, AU400/AU400 e ALKALINE PHOSPHATASE (IFCC) Cat. No.: OSR6x04 Reagent ID: 004

Beckman Coulter System Reagent, AU400/AU400 e Test Name: ALP < > Type: Serum Operation: Yes Sample: Volume 3 μl Dilution 0 μl Pre-Dilution Rate: 1 Reagents: R1 Volume 60 μl Dilution 60 μl Min OD Max OD