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Cat. No.

DC49A

Dimension® clinical chemistry system


Drug Calibrator II
Intended Use
Drug Calibrator II (Cat. No. DC49A) is an in vitro diagnostic product intended for the
calibration of the following methods packaged in Flex™ reagent cartridges:
Acetaminophen (ACTM)
Carbamazepine (CRBM)
Gentamicin (GENT)
Tobramycin (TOBR)
Valproic Acid (VALP)
Vancomycin (VANC)

Constituents
Drug Calibrator II is a liquid bovine serum base product containing the constituents
listed below. It is packaged as 10 vials, two vials each of five levels. Each vial contains
5.0 mL.

Precautions
This material should be handled using good laboratory practice to avoid skin contact or
ingestion.
For in vitro diagnostic use

Preparation
Allow vials to equilibrate at room temperature (22-28°C) before use.

Storage
Store at 2-8°C.

Stability
Unopened: See Expiration Date
Opened Vials: Once opened, assigned values are stable for 30 days when vials are
securely capped and stored at 2-8°C between use.

Calibration Procedure
Refer to the Operator’s Guide for the Dimension® clinical chemistry system.
Lot: H9810
Exp: 01 DEC 99

Assigned Values a,b,c


ACTM CRBM GENT TOBR VALP VANC
(DF88) (DF87) (DF12) (DF14) (DF78) (DF86)
UNITS µg/mL µg/mL µg/mL µg/mL µg/mL µg/mL
Level 1 0.0 0.0 0.0 0.0 0.0 0.0
Level 2 2.5 1.5 1.7 20.5 6.3
Level 3 75.0 5.1 2.9 3.1 39.4 12.4
Level 4 10.2 5.8 5.8 75.1 24.3
Level 5 315.1 20.4 12.0 12.4 159.7 50.3

SI UNITS d
µmol/L µmol/L µmol/L µmol/L µmol/L µmol/L
Level 1 0.0 0.0 0.0 0.0 0.0 0.0
Level 2 10.6 3.2 3.6 142.1 4.2
Level 3 496.2 21.6 6.2 6.5 273.0 8.3
Level 4 43.2 12.4 12.1 520.4 16.3
Level 5 2084.7 86.4 25.6 25.9 1106.7 33.7

a. Values for acetaminophen, carbamazepine, gentamicin, tobramycin, valproic acid and vancomycin
are assigned using USP reference standards prepared in human serum.
b. Users of this product will be notified if there is a change in an assigned value.
c. Use calibrator levels 1, 3 and 5 to calibrate acetaminophen (ACTM).
d. Système International d’Unites.

Dade Behring Inc.


Newark, DE 19714, U.S.A. PN 792049.100 3/99 Rev. C

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