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English
Inended use
Precconra) Growthis ued or quay een f speed mmunesesays
Sanaa "
Summary
Pretconts) Grouthisajephieed conte num seed on huran serum
MB corcentgon gee Tre goal ss ure fx ronson te
‘heuran on pocanh he Elsa IG, Ec FSP and NGH
‘inunoaseay
Reagents - working sltions
+ PCI: 2 betes, each fr 30 cert serum
+ PCG2:2beties each ar 30m cot enum
Sibsarcenhuran] POST POSE Unk
sen matix
a} [_#5 S ral
(eera [e00 7000 reat
[a fram
Target values and ranges
‘The target values and ranges were dternined and evlusted by Rech.
Taye cael ua fe Eos ey reagent ad anaes
svalabl a he tne testing
“The conrol trpet values and ranges ate encoded star in the barcode or
inthe electrona baeods (rich avaiable va he eabas Ink,
cobas 0411, cobas 2601 arc cobas w &2 analyzes: The value sheets
ahi terete da od oleroncay vate
Ith target values and contol res are updated, his infomaion is
Ccenvejazetrera tre repel arcades, of cor) barcodes (or provided
‘cectercaly) andi an aastoral velis sheelndused inte reagent i
‘ras value sheet les al corto| est which the new values opp sor
the vale remain uncsanged te orginal vales and he erigmal value
Shastri nthe core tren vad,
tcobas 0402 and cobas e801 analyzers: Theta
(engral and updated) ard value shest ar ony av
va be cobas ink
esuts muctbe wihin the spect ranges. Inthe event thal nereasng or
Gecresseg ends, ary Cher sutdeny oscurg devsbersbeyora ie
range mts are observed, al tet steps musi be checked.
anaes, neasromart lbp sen ed bo
repeat
Traceabilyinfarmation is given in the Mathed Sheet fhe relevant Elecsys
assy.
Each isboratory chou sstablch corectve measures tobe token fakes
Fallotside te defred its.
Pracautins and warnings
For invite dagneste use fer heath care prlessiona, Exercise the
‘oral pecavionsreqated fr hancirg alllaboralry reagets,
Infectious or microbial waste:
Warning: anda waste as pot biohazardous material, Dispose of
waste aecoing to accepted laboratory ins ctons and procedues.
Environmental hazards:
‘apy al lear lca ispsal yogulatons te determine the sale spas
‘Safety date sheet avaiable fer prloesional user on request.
Fer USA: Caution: Federal law rostres this vce to saleby oron he
corde of aphysican.
THis sons congeors dasied as folowsmeecorsarc wi te
Regulation (£6) No. 12722008;
value and rerges
lecreneaty
Page 1
cobas”
Very tox aquate Me wth long tctng ates,
‘void reaacot the environment
Coit
09,
Disposal:
Poot
Dispose of coxertztertainer to an approved was
‘disposal plant
Produc aft abeeg flows EU GHS guidance.
Corte phon: al counties: +19-621-7500, USA: 200-420-2006
‘Nlfurran material shoul be corsiteredpotstallyinfoeneus, Al protucs
ered ram human load are prepared exclusvel "ar he bland of
doors tested nd idly and shown foe ia rom HB