Thermo Scientific MAS Diabetes Guide Rapide

DBCL18041
DBCL18042
2018-04-30
®
MAS Diabetes
L A D
IQUID SSAYED IABETES
I U
NTENDED SE
MAS ® Diabetes is intended for use as an assayed control material for monitoring Glycosylated
Hemoglobin (A1c) assay procedures.
P D
RODUCT ESCRIPTION
Diabetes is an assayed product prepared from human whole blood adjusted to specifi c
concentrations of glycated hemoglobin. Preservatives and stabilizers are added to maintain
product integrity.
CAUTION: Diabetes is prepared from human source material. Components of the control which are
derived from human source material have been tested using FDA accepted methods and found non-
reactive for Hepatitis B Surface Antigen (HBsAg), Hepatitis C (HCV), HIV-1 and HIV-2. However, no
test method can offer complete assurance that products derived from human source material are
free of infectious agents. This control must be handled in accordance with recommendations from
Centers for Disease Control/National Institutes of Health manual, "Biosafety in Microbiological and
Biomedical Laboratories," 2009.
CAUTION: The packaging of this product contains dry natural rubber.
S A S
TORAGE ND TABILITY
Diabetes stored at -25 to -15°C is stable until the expiration date on the box. Once opened,
vials of Diabetes are stable for 30 days when stored tightly capped at 2-8°C. Unopened vials of
Diabetes are stable for 60 days from receipt when stored at 2-8°C. The control can be thawed
and refrozen one time. Self-defrosting freezers are not suitable.
Bacterial contamination produces an increase in turbidity and/or a characteristic odor.
Discard vial if evidence of microbial contamination is observed.
C R
ONTROL ANGES
The assigned ranges for these controls are based upon replicate assays of representative
samples of the product by participating laboratories in accordance with established protocol.
All values have been assigned with instruments and instrument manufacturer's reagents
available at the time of assay. Subsequent instrument or reagent modifi cations may invalidate
these assigned ranges.
Expected values may vary slightly with different reagent and/or methodologies used. Refer to the
included table for values obtained for specifi c systems. Values listed are specifi c for this lot of
control only. Good laboratory practice suggests that each laboratory establish its own parameters.
I F U
NSTRUCTIONS OR SE
Thaw control at room temperature (18-25°C) on a rocker or with periodic gentle inversion until
liquid and then immediately store at 2-8°C. Thoroughly mix the contents of the vial before each
use by gently inverting for several minutes. Open the vial and transfer the required quantity of
control into a clean sample cup. Replace cap immediately and store the opened vial at 2-8°C.
Assay controls in accordance with the reagent manufacturer's assay's and/or instrument's
instructions for unknown specimens.
Q C
UALITY ONTROL
All quality control requirements should be performed in conformance with local, state and/or
federal regulations or accreditation requirements.
C
ONTROL
L O P
IMITATIONS F ROCEDURE
Values for each lot are given in the product insert. Different laboratories, however, may expect
slightly different results. It is recommended that each laboratory establish its own expected range.
Accurate and reproducible results are dependent upon properly functioning instruments,
reagents, and good laboratory technique. This product is intended for use as an assayed control
for quantitative assays of listed constituents in human whole blood. This product is not intended
for use as a calibrator. For professional use only.
T A
ECHNICAL SSISTANCE
In the USA, for technical assistance, call 800-232-3342 or 510-979-5417. For insert updates and
information, if your laboratory subscribes to LabLink xL, visit www.maslablink.com and select
LabLink Extra. Alternatively, to subscribe to LabLink xL call 800-232-3342 or 510-979-5451.
Outside of the USA, if your laboratory subscribes to LabLink xL, visit www.maslablink.com
select LabLink Extra. Alternatively, please contact your local sales offi ce or authorized
distributor.
Cat. No.
DBCL-MP
Description
MAS ® Diabetes, Multi-Pack
Size
6 x 1 mL