snxu 8UJi Ej ït@@@@@/ Ceztificate of Analysis D!

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t3105QRO06 Ê1. OÏ

Certificate of Analysis
2022081001
L¥E-1 Qgg/Mfd. 2021. 03.22

500¥L 2024. 08. 09

SpeciÑcations

ÎÊ$ÈÎÎÊ@/Stantnrd
/CheckinR projwt

OKŒNG
fThe reagent is clear liquid, and it has no precipitation, granule and Boccules.

OKŒNG
@1abelIing and /a)The product name, lot number, production date, validity period and net
volume are correct; b)The sticker position is correct; c)T1ic product specification
fltStfillttf0R is in accordance with theproduct.
l& JMH/Reagent spécification
O 1 L D4 L O 10L D 20 L D KÑ 11.0% (1L<V <20 L)
/OthSf

500 mL O &U/other Œ-1.5% ( 500 mL <V < l L ) 504 OK ONG

fPacking Volumes O100 mL 0200 mL D ts/other 0-3.0% ( 100 mL <V < 500 mL )

OPO mL 0 &Ÿ/other 0-6.D% ( V< COO iñL )

N : &B Q V Jfj JQ/ The V ofpacking volumes t represents the reagent écification
sp

pH LYE- l ff8lff/ LYE-1 Lyse : 4.20:1:0.20 , 25.0:£ 1.0°C 4.23

/pH Value O DIL-E ÑÑÑ/DIL-E Diluent : 7.6010.20 , 25.OU.0°C / LOK ONG

DIL-E OWiàfDIL-E Diluent : (16.00ù0.50) mS/cm , (25.011.0)°C DOK ONG

saaæ DIL-E fiflJii /DIL-E Diluent : (310::£ 10)mOsm/kg OOKDNG

/Osmotic Pressure
LYE-1 âÏïtflf : jay ÜŸ Ñ(536:£ l0)nm
/LYE- l Lyse:taxis within the range o(536t 10) nm 538 LOK ONG

DIL-E &JÑ : ÑŸ&Ti k2.5fL f ÑŸ&A U2.5 X 10'/L

OOKONG
/DlL-EDiluent : Volumeh2.5fL,Particlc count62.5 x 10 /L

WBC s0.2 x 10 /L 0
LYE-1 îfiJÎIlflf/LYE-lLyse LOK ONG
HGB s 1 g/L 0
 bs) &ïsi8 &iàss«&Ü&
aaaasw
Histograni Of /a) There are two peaks in the WBC
WBC OKONG
histogram at least, one is representative
LYE-1 JÎItflf/LYE- lLysc small cells, and another one is Qualified
representative big cells; O K Unqualified
b) Confound to the shape of the
corresponding scatter diagram of WBC
and the scarier mark of the Dymind
analyzer.

ÎÑtl§Jäj@ z|z: DNR-NB-002[1.0}

 dItRQfF]fiJtj6JRDQ/ Certificate of Analysis 003 I0SBR006 1. 04

ABC f£ * 5. 0$ [Q' H
/WBC is within the range of +5.0%
0. 0$
LYE- 1 fiy UHf/LYE- 1 Lyse
hGB fi * 2. 6$/ñ fi Q
/HGB is within the range of +2. ñ%
-0. 7$
E8C A 15. R M t*4
/WBC is within the range of +5.0%

## Ae,uracy /HGB is within the range of +2.5%

RBC f£ * 2. 5$ @@
DIL-E N& /DIL-E Diluent : /RBC is within the range of +2.5%
flCv R * 3. &;z [fj H
is within the range of £3.0%
PU H * 8. 0$;* @
/PLT is within the range of +8.0%

ONG

/Remark

PS : 1 Fi lling the "V" Inside the box wh ich you need to select;
2 FH I ing in cross out with the “F’ inside the box which you hon' t need;

3. ”Ofi”means pass, “NG”means r«r1 pass.