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"DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro reagent for the determination of the dibucaine number to be used in conjunction with the in vitro test Cholinesterase Gen.2, Cat. No. 08105561190, on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

To determine the dibucaine number (DN), cholinesterase activity is measured with and without enzyme inhibitor dibucaine. The dibucaine number is calculated as follows:

DN = 100 −

CHE activity with inhibitor
CHE activity without inhibitor

× 100

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08105570190

Dibucaine (1050 tests)

System‑ID 2038 001

cobas c 303, cobas c 503

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

DIBU: ACN 20380

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

26 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Performance data

See Method Sheet for CHE2.

", "Language": "en" }, { "Name": "Precision", "Value": "", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents – working solutions

R2 (Special reagent)

Dibucaine: 2.6 mmol/L, pH 6.3

R2 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

For details see Method Sheet for CHE2.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0005168511190c701", "ProductName": "DIBU", "ProductLongName": "Dibucaine", "Language": "en", "DocumentVersion": "5", "DocumentObjectID": "FF00000004BE930E", "DocumentOriginID": "FF00000000FFB20E", "MaterialNumbers": [ "05168511190" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro reagent for the determination of the dibucaine number to be used in conjunction with the in vitro test Cholinesterase Gen.2, Cat. No. 05168503 190, on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

To determine the dibucaine number (DN), cholinesterase activity is measured with and without enzyme inhibitor dibucaine. The dibucaine number is calculated as follows:

DN = 100 –

CHE activity with inhibitor

x 100

CHE activity without inhibitor

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

05168511 190

Dibucaine* (13 mL)

System‑ID 03 7458 8

Roche/Hitachi cobas c 701/702

* The value presented on the instrument inventory screen is around 9 mL to account for the dead volume of the containers. This corresponds to 400 tests.

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

DIBU: ACN 8015

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

DIBU

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

4 weeks

On‑board on the Reagent Manager:

24 hours

", "Language": "en" }, { "Name": "Calibration", "Value": "", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Performance data

See package insert for CHE2.

", "Language": "en" }, { "Name": "Precision", "Value": "", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagent – working solution

R2 (Special Reagent)

Dibucaine: 2.6 mmol/L, pH 6.3

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

For details see package insert for CHE2.

", "Language": "en" } ] } } ] }

DIBU

Dibucaine

IVD For in vitro diagnostic use.
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    SVTCH
    SVTCH ONLINE DAT Specimen Validity Test Chromate
    GPR For general laboratory use.
    SVTNI
    SVTNI ONLINE DAT Specimen Validity Test Nitrite
    GPR For general laboratory use.
    SVTOX
    SVTOX ONLINE DAT Specimen Validity Test Oxidant
    GPR For general laboratory use.
    SVTpH
    SVTpH ONLINE DAT Specimen Validity Test pH
    GPR For general laboratory use.
    SVTSG
    SVTSG ONLINE DAT Specimen Validity Test Specific Gravity
    IVD For in vitro diagnostic use.
    SALI
    SALI Salicylate
    IVD For in vitro diagnostic use.
    THC2
    THC2 ONLINE DAT Cannabinoids II
    IVD For in vitro diagnostic use.
    TRSF2
    TRSF2 Tina-quant Transferrin ver.2
    IVD For in vitro diagnostic use.
    TPUC3
    TPUC3 Total Protein Urine/CSF Gen.3
    IVD For in vitro diagnostic use.
    UREAL
    UREAL Urea/BUN
    IVD For in vitro diagnostic use.
    UIBC
    UIBC Unsaturated Iron-Binding Capacity
    IVD For in vitro diagnostic use.
    TP2
    TP2 Total Protein Gen. 2
    IVD For in vitro diagnostic use.
    UA2
    UA2 Uric Acid ver.2
    IVD For in vitro diagnostic use.
    TRIGL
    TRIGL Triglycerides
    IVD For in vitro diagnostic use.
    VALP2
    VALP2 ONLINE TDM Valproic Acid
    IVD For in vitro diagnostic use.
    ALTP
    ALTP Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation
    IVD For in vitro diagnostic use.
    ASTP
    ASTP Aspartate Aminotransferase acc. to IFCC with pyridoxal phosphate activation
    IVD For in vitro diagnostic use.
    KFLC
    KFLC Kappa (κ) Free Light Chains
    IVD For in vitro diagnostic use.
    LFLC
    LFLC Lambda (λ) Free Light Chains
    IVD For in vitro diagnostic use.
    A1CD
    A1CD Hemolyzing reagent
    IVD For in vitro diagnostic use.
    MYO2
    MYO2 Tina-quant Myoglobin Gen.2
    IVD For in vitro diagnostic use.
    6AM
    6AM 6-Acetylmorphine Enzyme Immunoassay
    IVD For in vitro diagnostic use.
    BUP
    BUP Buprenorphine Enzyme Immunoassay
    IVD For in vitro diagnostic use.
    EDDP
    EDDP Methadone Metabolite Enzyme Immunoassay
    IVD For in vitro diagnostic use.
    FEN2
    FEN2 Fentanyl II Enzyme Immunoassay
    IVD For in vitro diagnostic use.
    ASTPM
    ASTPM Aspartate Aminotransferase acc. to IFCC with pyridoxal phosphate activation
    IVD For in vitro diagnostic use.
    SDLDL
    SDLDL small dense LDL Seiken
    IVD For in vitro diagnostic use.
    A1MGU
    A1MGU α1-Microglobulin
    IVD For in vitro diagnostic use.
    ALTPM
    ALTPM Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation
    IVD For in vitro diagnostic use.
    HYD
    HYD Hydrocodone Enzyme Immunoassay
    IVD For in vitro diagnostic use.
    ALT
    ALT Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation
    IVD For in vitro diagnostic use.
    AST
    AST Aspartate Aminotransferase acc. to IFCC without pyridoxal phosphate activation
    IVD For in vitro diagnostic use.
    A1C-3
    A1C-3 Tina-quant Hemoglobin A1c Gen.3
    IVD For in vitro diagnostic use.
    Antithrombin III
    Antithrombin III Antithrombin III
    IVD For in vitro diagnostic use.
    A1MG2
    A1MG2 Tina-quant α1-Microglobulin Gen.2
    IVD For in vitro diagnostic use.
    ALTL
    ALTL Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation
    IVD For in vitro diagnostic use.
    DBILI
    DBILI Direct Bilirubin
    IVD For in vitro diagnostic use.
    ALTLP
    ALTLP Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation
    IVD For in vitro diagnostic use.
    ASTLP
    ASTLP Aspartate Aminotransferase acc. to IFCC with pyridoxal phosphate activation
    IVD For in vitro diagnostic use.
    ASTL
    ASTL Aspartate Aminotransferase
    IVD For in vitro diagnostic use.
    CHED2
    CHED2 Cholinesterase / Dibucaine Gen.2
    IVD For in vitro diagnostic use.
    ALTL
    ALTL Alanine aminotransferase acc. IFCC with or without pyridoxal phosphate activation
    IVD For in vitro diagnostic use.
    CRPLX
    CRPLX C-Reactive Protein (Latex)
    IVD For in vitro diagnostic use.
    K
    K ISE Potassium Electrode
    IVD For in vitro diagnostic use.
    D-DI2
    D-DI2 Tina-quant D-Dimer Gen.2.
    IVD For in vitro diagnostic use.
    cobas c 513 analyzer
    cobas® c 513 analyzer The cobas c 513 analyzer is a dedicated high throughput HbA1c solution designed to manage the increasing HbA1c testing volume.
    IVD For in vitro diagnostic use.
    cobas c 303 analytical unit
    cobas® c 303 analytical unit Combining photometric and ISE testing on a footprint of just 1.2 square meters.
    IVD For in vitro diagnostic use.
    cobas c 503 analytical unit
    cobas® c 503 analytical unit cobas c 503 analytical unit for clinical chemistry
    IVD For in vitro diagnostic use.
    cobas c 111 analyzer
    cobas® c 111 analyzer The cobas c 111 analyzer is the ideal compact benchtop solution for clinical chemistry testing in laboratories running up to 50 samples per day.
    IVD For in vitro diagnostic use.
    cobas c 311 analyzer
    cobas® c 311 analyzer The cobas c 311 analyzer is a stand alone system that offers consolidated testing from a broad menu of clinical chemistry applications.
    IVD For in vitro diagnostic use.
    cobas c 702 module
    cobas® c 702 module The cobas c 702 is a high volume analyzer for clinical chemistry assays and for measuring HbA1c levels in whole blood for medium test volumes.
    IVD For in vitro diagnostic use.
    cobas c 701 module
    cobas® c 701 module The cobas c 701 is a high volume analyzer for clinical chemistry assays and for measuring HbA1c levels in whole blood for medium test volumes.
    IVD For in vitro diagnostic use.
    Accutrend® Plus system
    Accutrend® Plus system The Accutrend® Plus system is a flexible hand - held device for the key parameters used to detect cardiovascular disease.
    IVD For in vitro diagnostic use.
    PREA
    PREA Prealbumin
    IVD For in vitro diagnostic use.
    ACET2
    ACET2 ONLINE TDM Acetaminophen Gen.2
    IVD For in vitro diagnostic use.
    VANC3
    VANC3 ONLINE TDM Vancomycin Gen.3
    IVD For in vitro diagnostic use.
    THEO2
    THEO2 Theophylline
    IVD For in vitro diagnostic use.
    TOBR2
    TOBR2 ONLINE TDM Tobramycin
    IVD For in vitro diagnostic use.
    DIG
    DIG Digoxin
    IVD For in vitro diagnostic use.
    LI
    LI Lithium
    IVD For in vitro diagnostic use.
    CKMB
    CKMB Creatine Kinase-MB
    IVD For in vitro diagnostic use.
    CHOL2
    CHOL2 Cholesterol Gen.2
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