ERBA ELite 5 - Page 161

Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ
e-mail: diagnostics@erbamannheim.com, www.erbalachema.com
Erba Diff-5P
WBC di󰀨erentiation reagentfor automated analyzers
Name Cat. No. Package volume
Erba Di󰀨-5P HEM00002 1 L
For in vitro diagnostic use only
INTENDED USE
Erba Di󰀨-5P WBC di󰀨erentiation reagent is a stabilized and
micro-ltered reagent for quantitative determination of leu-
kocytes (WBC), leukocyte 5-part di󰀨erentiation (LYM, MON,
NEU, EOS, BAS) and hemoglobin (HGB) concentration me-
asurement of human blood on hematology analyser.
Erba Di󰀨-5P WBC di󰀨erentiation reagent should be used
with only Erba Lachema reagents. Erroneous results may
be obtained if the reagent is applied with third party rea-
gents.
Please refer to the instrument’s User Manual for further in-
formation.
INGREDIENTS
Sodium salts < 3.4 %
Bu󰀨ers < 1.2 %
Preservative < 0.5 %
Stabilizers < 0.5 %
in ion-free water
HANDLING PRECAUTIONS
- Erba Di󰀨-5P di󰀨erentiation reagent is environmental frien-
dly, cyanide-free and azide-free reagent; does not contain
harmful ingredients.
- Avoid contact with eyes, skin and clothing.
- In case of eye or skin contact ush eyes with copious
amounts of water for several minutes or wash skin area with
water.
- Keep the reagent container closed when not in use.
- Wear laboratory gloves when handling the reagent.
- All body uid samples should be considered potentially
infectious materials. Treat all blood and other potentially in-
fectious materials with appropriate precautions. Use gloves,
masks and gowns if blood exposure is anticipated.
- Use Good Laboratory Practices (GLP) when handling the
reagents.
SPECIMEN COLLECTION AND PREPARATION
Erba Di󰀨-5P reagent is intended for use with blood specimens
collected by vein puncture in EDTA anticoagulant. Specimens
for hematological analysis may be stored for up to 8 hours at
(+15 to +30) ºC or up to 24 hours after collection when refri-
gerated (+2 to +8) ºC.
REAGENT PREPARATION
- This reagent is ready for use and can be applied straight from
the container; no special reagent preparation is necessary.
- Leave the reagent at room temperature for at least 12 hours.
REAGENT REPLACEMENT
- Person installing the reagent must be a trained laboratory
professional.
- Remove the inlet cap from the reagent container to be repla-
ced. Connect the reagent inlet to the new reagent container.
- Be sure that the colour on each tube, reagent container
label and connector in the back of the instrument match.
- Avoid any dust or microbial contamination of the tubing
and reagents. Do not pour and mix the remains of a reagent
from a container into other one.
- Prime thoroughly the new reagent and measure backgrounds
according to the instrument’s User Manual.
- When installing a new lot of reagent, recalibrate the instru-
ment as specied in your User Manual.
REAGENT STORAGE, STABILITY AND DISPOSAL
- Store Erba Di󰀨-5P WBC-5-part reagent between +15
and +30°C.
- The shelf life of the Erba Di󰀨-5P WBC-5-part reagent is 24
months from date of manufacture, if stored at the prescribed
temperature range.
- Do not use reagent beyond the expiration date printed on
the container label.
- Discard opened container after 120 days.
- Do not use reagent once frozen.
- Dispose of waste product, unused product and contamina-
ted packaging in compliance with local regulations.
IVD
Hematology reagents
See Instruction for Use
i
Catalogue Number Lot Number
Expiry date
In vitro Diagnostics
Storage Temperature Content
CONT
Manufacturer
REF
CE Mark -
Device comply with
the Directive 98/79/EC
USED SYMBOLS
IVD
HEMA/PI/05/17/B Date of revision: 25.7. 2017
50003766