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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.

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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

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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

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Reagent handling

Ready for use

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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

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Performance data

See Method Sheet for CHE2.

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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.

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Specimen collection and preparation

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

For details see Method Sheet for CHE2.

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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

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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

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Performance data

See package insert for CHE2.

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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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