Beckman Coulter MicroScan B1016-138 Manuel D'utilisation page 14

Symbol
C29870–AD
Symbols Key
Symbol Title
Batch Code
Catalogue Number
Manufacturer
Date of Manufacture
Authorized Representative
in the European Community
Contains sufficient for <n>
tests
In Vitro Diagnostic Medical
Device
Temperature Limitation
Consult Instructions for Use
CE Mark
Contents
Contents (package)
Contents (package)
Safety Data Sheet
Made in USA
For Export Use Only
Reconstitution Volume
Fragile, handle with care
This way up
Description of Standard Standard
Indicates the
manufacturer's batch
code so that the batch or
lot can be identified.
Indicates the
manufacturer's catalogue
number so that the
medical device can
be identified.
Indicates the medical
device manufacturer, as
defined in EU Directives
90/385/EEC, 93/42/EEC
and 98/79/EC.
Indicates the date when
the medical device was
manufactured.
Indicates the authorized
representative in the
European Community.
Indicates the total number
of IVD tests that can
be performed with the
IVD. (Typically included
on reagent kits).
Indicates a medical device
that is intended to be used
as an in vitro diagnostic
medical device.
Indicates the temperature
limits to which the medical
device can be safely
exposed.
Indicates the need for
the user to consult the
instructions for use.
European Conformity
Regulatory Mark
n/a
Antimicrobial Agent
(abbreviation)
Identification Substrate
(abbreviation)
Indicates a safety
data sheet.
n/a
n/a
n/a
Indicates a medical
device that can be
broken or damaged if
not handled carefully.
Indicates the correct
upright position
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ISO 15223-1; 5.1.5
ISO 15223-1, clause 5.1.6
ISO 15223-1, clause 5.1.1
ISO 15223-1; 5.3.1
ISO 15223-1, clause 5.1.2
ISO 15223-1; 5.5.5
ISO 15223-1, clause 5.5.1
ISO 15223-1; 5.3.7
ISO 15223-1; 5.4.3
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
ISO 15223-1; 5.3.1
ISO 7000: 0623