Z Biotech Anylab F1 Brochure

2018.
01 Registration for Domestic market CRP and PCT in Korea(KFDA)
2017. 12
An agreement for the K-start up project(Ministry of SMEs and Startups)
2017. 08 Registration for Overseas market AnyLab F1 and reagents (KFDA)
2017. 04 Registration of rapid test for veterinary(Animal and Plant Quarantine Agency)
Registration for Domestic market AnyLab F1 device(KFDA)
An agreement for the Advenced Technology Center project(Ministry of Trade Industry and Energy)
2016. 06 Designation as a promising company in export (CBTP, Chungbuk Regional Small & Medium
Business Administration)
2016. 05 Designation as a company to participate in New Local Business Leading Manpower
Cultivation Project (Ministry of Science, ICT and Future Planning)
2016. 04 Acquisition of a licence for the export of animal medicine and medical supplies
(Total 9 items)
2016. 02
2015. 12
2015. 11 Acquisition of CE for a malaria and dengue diagnostic kit
2015. 10 Economic cooperation business cultivation project
(Ministry of Trade, Industry and Energy)
Conclusion of MOU for creative economic corporation supportive cooperation
(CBTP, Chungbuk Creative Economic Innovation Center)
2015. 09 Prompt industrialization support project (Fast-Track) (CBTP)
2015. 07 Designation as a company to supervise creative convergence R&D project
(Ministry of Trade, Industry and Energy)
2015. 06 Industry-academy-institution cooperative technical development project
(Small and Medium Business Administration)
2015. 04
2015. 02 Opening of an R&D institute (Korea Industrial Technology Association, KOITA)
2014. 12 Foundation customized business (Foundation Promotion Center)

2014. 11 Establishment of an exclusive R&D division
(Korea Industrial Technology Association, KOITA)
Registration of a factory for manufacturing medicine and medical supplies
(Cheongju City Hall)
Foundation developmental technology development project
(Small and Medium Business Administration)
2014. 08 Registration of a factory - Registration of a factory for manufacturing medical equipments
2014. 06 Acquisition of a licence for manufacturing medical equipments (MFDS, KFDA)

2014. 05 Establishment of ZET BIOTECH Inc.
Cancer
Hormone
Inflammation
Diabetes High-Sensitive IVD POCT System
Ohters
ANYLAB-F1 is a POCT (Point Of Care Test) system

that is based on immunofluorescence and test
diagnostic items with the samples - serum, plasma,
whole blood or urine like a large centralized
system, so it can obtain results easily and quickly
(3~15mins).
In addition, the system has used the immuno-

fluorescence method which is 10~100 times more
sensitive than the colorimetry method, so it can
achieve quantitative results with s higher degree
of accuracy, making the test more useful.
SPECIFICATION
Release Status of each Parameter Dimensions 305 x 260 x 115 mm
Weight 2.2 Kg
Hormone Hormone
for Pregnant for Thyroid Diabetes
Power Supply 220 V, 5a
FSH TSH *HbA1c
β-hCG Free T4 *Microalbumin
Data Presentation LCD/Printer/Android
LH Total T3 Working Temp. 15 ~ 35℃
PRL Total T4 Inflammation Working Humidity Max 70%
*Cortisol CRP
*Testosterone Cancer PCT
*Progesterone AFP
CEA Others
PSA Ferritin
*FOB *Vitamin D
*Coming Soon
RM472, E-9 Bldg., Chungdae-Street No.1, Seowon-District,

Cheongju-City, Chungcheongbuk- Province, South Korea www.zetbio.com
Pregestational
Cancer
Cardiac
Inflammation
Thyroid Hormone
Hormone
TSH
AFP
CK-MB
Beta-hCG
CRP
Free&T3hsCRP
Ferritin
Myoglobin Product that can check pregnancy
Product that canand normal/abnormal
check hsCRP and CRPpregnancy
both. both.
Important
Most measurement
marker of malignant in the assessment
tumors such ofasthyroid
liver function.
cancer and testicular cancer.
A key of Anthem
marker is abnormal
of found
iron-containing
Important in the
measurement heart
pregnancy
protein muscle.
in -> status,
theThe Once
ironsuch the heart muscle
asofpregnancy
component
assessment thyroid outisin
is stored
function. damaged,
of pregnancy
the its concentration
protein. will increase.abortion.
and sudden spontaneous
The
Major main marker
Itusedrole
Sensitive
plays of
for clinical
to
hypothyroidism
a arole in status
infection,
reserving after
and treatment
inflammation,
andorsupplyingand and monitoring
tissue
hyperthyroidism.
oxygen damage.
that the
exists evaluation
in muscles of (It can transport oxygen around
ItThis marker
is also When
Major isasused
iron
marker for
tumor
content the
for early diagnosis
marker.
increases
hypothyroidism of acute
decreases,
and itmyocardial
acts as
hyperthyroidism. infarction.
a buffer.
treatment
After chest Used patients
as aincluding
clinical tool to monitor inflammatory processeswithin of autoimmune diseases and rheumatoid arthritis.
Measured musclestopain
30,000 occurs, mIUthe mlheart
/ iron muscle
atoms).
without cells step.
dilution will be damaged 3-8 hours. The concentration of CK-MB will
reach the Emerging as the strongest and most independent predictive risk tofactor for atherosclerosis and hours.
CVD.
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a Hemevalue proteinin 12-24 hours.
similar And its
to hemoglobin concentration
and the firstwill return
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myocardial necrosis.
400
100 If100theie is chest pain and the result value of CRP is between 0.1-10mg/L, probably can be judged as
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party control(ng/mL)
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after Detection
6-9 hours.
100
350 cardiovascular
y = 0.9618x
R²=
R²=
+ 226.88 y
0.9877
0.9841 disease
- 0.5206
or stroke(cerebral apoplexy). Range 0.1
1 - 400
- 100
ng/mL
ulU/mL
R²= 0.9725
Available
y = 1.0008x - 0.0338
as a
R²= 0.9796
sensitive indicator of acute
Concentration3rd party
myocardial
3rd party control(mlU/mL)
infarction.
control(ng/mL) Detection Range 15
80
20000 R²= 0.9979
30
32.3
0.659 126
5.28 270
26.4
Performance
3rd party Detection
Reaction
control(ng/mL) Range
Time 31 --min.
30,000
100 mlU/mL
ng/mL
300 80 y = 0.987x - 0.2143 Concentration
Concentration 7.37 26.9 408
Performance
AnyLab CV(%) 2.81 16.8
5.9 Concentration
9.3 6.8
7.3 Performance
93.9
6.453.4
6.1 Reaction412
Reaction Time
Time 15 min.
15 min.
F1(ulU/mL)
80 600
300 R²= 0.997 139
Anylab F1(mlU/mL)
F1(ng/mL)
Sample Volum 200

100 ul
Anylab F1(mlU/mL)
y = 1.0334x
0.9775x -+ 0.602
0.8667
250 25 AnyLab CV(%)
AnyLab CV(%)
Patient 9.4 7.1 3rd party
Samples(ng/mL) 5.2 control(pg/mL)
60 R²=
R²=0.9855
0.9919 Patient Samples(ulU/mL)
6.0 5.7
AnyLab CV(%)
5.1
Sample Volum 100 ul Plasma
F1(ng/mL)
15000 60
500
250 3rdparty
3rd
Concentration party control(ng/mL)
7.0 6.1
Sample
control(mg/L)
2.31 Sample Type
5.20
6.5
Volum
8.50 100 ul
Serum,
200
60 Patient Samples(ng/mL)
Concentration
Patient Samples(mlU/mL)
10.3
0.83 40.8
6.18 153.1
19.4
F1(pg/mL)
20
Patient7.06
Concentration
Concentration Samples(ng/mL)Sample38.8
Type Serum,Plasma
Plasma
Anylab
Anylab
37.9 126
Sample
20.9 301
Type Serum,
40 Concentration AnyLab CV(%) 5.74 Product
5.66 5.89 25 Test Kit
F1(ng/mL)
150
F1(mg/L)
10000 400
200
40 AnyLab CV(%) 4.7
7.1 30.6
6.2
9.7 Concentration
7.8 60.3
5.612.4
7.4
Anylab
AnyLab CV(%)
AnyLab CV(%) 5.4
6.9 82.5
6.1 132.0
Composition
Product5.25.9
5.4Product 25 Detection
25Test Kit Buffer
Test Kit
6.3 Patient6.4Samples(pg/mL) 25
40 15
100 AnyLab CV(%)
AnyLab CV(%)
Batch 6.9
Batch to
to Batch(10.0
Batch(10.0
6.2 ng/mL)
ulU/mL)
5.9 6.1 125C-card
Anylab
300 AnyLab CV(%)

Patient 6.3 Composition
Composition
Samples(ng/mL)
5.2 5.7 25 Detection Buffer
Detection Buffer
20 150
Patient Samples(mg/L)
Concentration 4.6 10.7 18.6
Anylab
5000
20 Batch to
to Batch(10.0ng/mL)
Batch(10.0mlU/mL) 11 C-card
C-card
Anylab
50 10 BatchBatch Lot1 Lot2 Lot3 Storage Test Kit: 2-30℃

20
Batch to 1.4
Concentration
Concentration Batch(20.0
12.8 ng/mL)
24.6
15.7 61.4
51.9
Batch AnyLab CV(%) Lot35.7 6.0
200
100
Batch
AnyLab CV(%)
Lot1
Lot1
7.3
7.8 Lot2
Lot2
6.9
7.1 Lot3
7.2Lot1
7.4 Storage 5.8
Temperature
Storage Detection
Test Kit:
Test Buffer: 2-8℃
Kit:2-30℃
2-30℃
0 50 100 150 200 250 300 350 400 Batch
AnyLab
AnyLab CV(%)
CV(%) 6.8
8.8 Lot2
6.2
5.8 Lot3
7.2
6.3
20 5 40 60 80 100 Batch to Batch(3.0 pg/mL)
Temperature Detection Buffer:
Buffer:2-8℃
2-8℃
0
0 5000 10000
20
15000
40
20000
60
30000 AnyLab CV(%)
80AnyLab CV(%)
100 6.1
6.1 5.8
5.9 6.4
6.3 Temperature Detection
1000
20 50 Roche
40Cobas C 411(ng/mL) AnyLab CV(%)
Batch to Batch(50.0
5.5 ng/mL)
5.1 5.4
Roche e411(ulU/mL)
BatchBatch to Batch(10.0 mg/L)
0 60 80 100
Roche e411(mlU/mL)
Roche e411(mlU/mL) Lot1 Lot2 Lot3
Roche Cobas
5
e 411(ng/mL)
10 15 20 25 30 Batch
Batch Lot1
Lot1 Lot2
Lot2 Lot3
Lot3
0
AnyLab CV(%) 5.8 6.1 5.9
00 50
100 100 150 200
VIDAS System(pg/mL)
200 300 400 250
500 300
600
AnyLabCV(%)
AnyLab CV(%) 5.7
6.1 6.86.2 5.3
5.9
Roche Cobas
Roche C 701(mg/L)
e411(ng/mL)
AnyLab F Ferritin
Total
LH AnyLabT3
CEA
D-Dimer F Free T3 Detection Range
10 - 1,000 ng/mL Product 25 Test Kit
AnyLabFFCRP/
AnyLab Myoglobin
hs CRP Composition 25 Detection Buffer
T3
LHplays
Major helps Reaction
aregulate
marker roleof
Detection Time
ascolorectal
athe
thyroid
Range 15 min.
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thrombus
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Composition
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y = 1.025xSample
- 0.5206 Type Serum, Plasma Storage 2-30℃
3rd party control(mlU/mL) Detection
Sample
R²= 0.9796
Type Serum, Plasma Temperature
Temperature DetectionBuffer:
Detection Buffer: 2-8℃Range
2-8℃ 1 - 100 mlU/mL
10,000 Sample Type Whole blood, Serum, Plasma
Concentration 3rd party4.19 21.8 72.8
y = 0.9796x - 7.087
807
200
yy== 1.0058x -- 0.0392
R²= 0.999
1.0014x 0.0299
control(ng/mL) Reaction Time
Detection Range 15-min.
50 10,000 ng/mL
3rd
3rd party
control(ng/mL) Detection Range 0.1
1 - 200
- 6.0ng/mL
ng/mL
AnyLab CV(%)
F1(mlU/mL)
8,000 R²=
R²=0.9898
0.988
460 1,709 6,446
6
Concentration 2.5
0.981 16
2.16 37.7
3.34
Reaction
Sample Time
Volum 15
100min.
ul
60
AnyLab CV(%)
Reaction Time 15 min.
F1(ng/mL)
150 5.9 6.4 5.7

AnyLab CV(%) SampleVolum
Sample Type Serum,
100 ul Plasma
Free T4
Prolactin
9.2 6.4 5.8
F1(ng/mL)
5 5.51 4.54 4.53
TnIPCT
Concentration
F1(ng/mL)
6,000 6.81
Patient Samples(ng/mL)18.6 51.6 Sample Volum 100 ul
Anylab
404 Patient
Patient Samples(ng/mL)
Samples(ng/mL) ProductType
Sample Serum,
25 TestPlasma
Kit
AnyLab CV(%)
Anylab
100 352 987 2,314 Sample Type

Composition Serum, PlasmaBuffer
25 Detection
Concentration
Anylab
4,000 2.8
0.9 9.4
2.3 24.5
4.8 Product 25 Test Kit
Batch to Batch(10.0mlU/mL)
Anylab
3
AnyLab CV(%) 5.8 6.2 6.0 Product 1 C-card
25
20
A
Thismarker
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the diagnosis the of hypothyroidism 9.7 and hyperthyroidism. 25 Test Kit Buffer
Troponin: protein found inin
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AnyLab
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BatchBatch
6.23
Lot1 muscle
6.5
5.78
Lot2 fibers.
6.1
5.32
Lot3
Composition
Composition
Storage 25
Detection
Detection Buffer
2 to Batch(10.0ng/mL) 1Test Kit: 2-30℃
C-card
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50
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Decrease
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Batch(10.0
Batch(10.0 TnI.
ng/mL) Temperature 1Detection
C-card Buffer: 2-8℃
Common marker for sepsis. BatchCV(%) 7.2
Lot1 7.4
Lot2 7.7
Lot3 Storage Test Kit: 2-30℃
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20 exists
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Storage injury. Test Kit: 2-30℃
Rapidly rising after a bacterial infection has
AnyLab CV(%) occurred.
6.0 6.1 5.8 Temperature Detection Buffer: 2-8℃
0 2,000 Roche
4,000e411(mlU/mL)
6,000 8,000 10,000
AnyLab CV(%) 8.3
5.05 8.4
5.16 7.8
5.22
Temperature Detection Buffer: 2-8℃
0 An50 effective 100test for antibiotic
150 prescription.
200
Performance
0 1 2 VIDAS Systems(ng/mL)
3 4 5 6 7
100
10
30 Roche y Cobas
= 1.025x
y Roche
- 0.5206
e411(ng/mL)
e411(ng/mL)
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y = 0.9936x+ 0.0924
+ 0.089
Performance
Performance
R²= 0.9796
50
80
R²=
R²= 0.9481
0.9917
y = 1.0358x - 0.1241
3rd Performance
25
8 3rd
3rd party
party control(ng/dL)
control(ng/mL)
Concentration
proBNP
R²= 0.9863 5.16 14.5 31.9
Anylab F1(mlU/mL)
3rd party 0.313

control(ng/mL)
FSH
40 Concentration
Concentration 0.915 2.08
1.15 2.91
3.72
AnyLab CV(%)
F1(ng/dL)
6.9 5.6 5.2

F1(ng/mL)
2060
Total
PSA T4
Concentration
AnyLab 0.567 1.72 16.1
AnyLab CV(%)
6 8.1 9.3 8.9
CV(%) 6.13 5.87 5.96
F1(ng/mL)
30
15 AnyLab CV(%)Patient9.4Samples(ng/dL)
6.7 6.3
40
ConcentrationPatient Samples(ng/mL)
Anylab
Egg stimulation hormone 21.4 57.3 123.2

Anylab
BNP(Brain 4
Natriuretic Peptide) is mainly produced in the ventricles. It
Patient
Concentration
Concentration
is also known
Samples(ng/mL)
0.83 6.18 as B-type.
19.4 Pro-BNP is the
0.5 6 12
It`s oneovulation,
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pro-protein of
20 tothe a
of two
low major
level
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male blood. by the thyroid gland,
AnyLab also converted 6.1 to T35.9 in the liver or other tissues.
Anylab
Before 10
20 the concentration increased rapidly. It goes up with
CV(%)
Concentration
AnyLab CV(%)
LH. 7.4
0.48
9.3 15.38.6 20.3
8.7
AnyLab CV(%) 5.97 8.6 8.7
Associated
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5 difficulty
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AnyLab CV(%)Batch to9.8
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hyperplasia
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there is expansion of the ventricular Batch
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10
Batch of TSHLot1 is suppressed.
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100
It isy checked 0 to diagnose
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40 60 or80severity
100 of renal insufficiency.
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AnyLab CV(%)
Lot1
Lot1
5.5
Lot2
Lot2
5.7
Lot3
Lot3
5.6
30 0 5 2 10 4 15 6 20 8 25 10
30 Batch CV(%) Lot1 Lot2 Detection
Lot3 Range 1 - 100 mlU/mL
90
50 R²= 0.9846
y =y 0.9894x
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0
0.3484 Roche e411(mlU/mL) AnyLab
AnyLab CV(%) 8.4
6.23 8.6
6.11 8.3
5.89
- 0.5206
3rdparty
50 3rd
40Concentration partycontrol(ng/mL)
control(ug/dL) Detection Range 0.5
0.1 -min.
25.0
100 ng/mL
ug/dL
3rd party8.28 22.1 50
25,000 Roche
80 0 10 Roche e411(ng/dL)
20 e411(ng/mL)
30 control(pg/mL) Reaction
Detection Time
Range 115
- 30,000 pg/mL
R²=
R²= 0.993
y = 1.0039x - 12.467
0.9796 AnyLab CV(%) 6.8 7.4 6.2
25 R²= 0.9984 Concentration
AnyLab CV(%) 4.50
0.334 10.1
3.84 18.5
25
F1(mlU/mL)
70
40 Roche e411(ng/mL) 90.4 275 3,998 Reaction Time 15 min.
20,000 Sample Volum 100 ul
60
AnyLab F Prolactin AnyLab CV(%) 5.81
6.8 6.01
7.1
Patient Samples(mlU/mL) 5.77
6
AnyLab CV(%) 5.4 5.9 5.7 Sample
SampleVolum 100 ul
20
F1(ug/dL)
AnyLab
AnyLab FF TnI
Free T4 Sample Type
Volum Serum,
100 ul Plasma
F1(ng/mL)
50
30 PatientSamples(ng/mL)
Patient
Concentration Samples(ug/dL)
F1(pg/mL)
6.12 18.01
Patient Samples(pg/mL) 33.57
Anylab
15,000
40
15 AnyLab F PCTRange
Detection 1 - 100 ng/mL Product 25 Test Kit Sample
Sample
Product
Type
Type Serum,
Serum, Plasma
25 TestPlasma
Kit
Concentration
AnyLab CV(%) Product
5.7
0.45 12.3
4.41 20.8
13.8
Detection
Detection Range Concentration 7.4 7.7 7.8
25
0.1
0.1 -- 8.0
25.0ng/dL 263 1,326 25Test
4,327 Kit
Anylab
Range ng/mL Product

Composition 25 Test Kit Product
Detection Buffer
Composition 25Test
25 Detection
Kit Buffer
Anylab
20
30
ReactionRange
Time 0.115- 100
min.ng/mL AnyLab CV(%) Composition
5.69
6.6
Product 6.15
5.9 25
5.74
5.8 Detection Product
Buffer 25 Test Kit
Anylab
10,000
10 Detection Batch toComposition
AnyLab CV(%) Batch(10.0 mlU/mL) 251Test
25 Kit Composition
Detection
C-card Buffer 1 C-card
25
25 Detection
Detection Buffer
Reaction Time 15 min. 6.3 6.0 6.1
20
Reaction Time 15 min. Composition 1
25 C-card Composition
Detection Buffer
1 C-card Buffer
SampleTime
Reaction Volum 15100min.ul Batchto
BatchBatch toBatch(10.0
Batch(10.0Lot2
Lot1 ug/dL) Lot3
ng/mL) Storage 1 C-card
1Test Kit: 2-30℃
10
10 Batch to Batch(10.0pg/mL)
Storage Test Kit: 2-30℃
1Test
C-card C-card
5
5,000 Sample Volum
Sample Volum 100
100 ulul Batch Storage Kit: 2-30℃Temperature Detection Buffer: 2-8℃
AnyLab Storage
Lot1
TemperatureLot2
Lot3 Kit: 2-30℃
Test
Lot3
Detection Storage
Buffer: 2-8℃ Test
Sample
Sample Type
30 Volum 60 200
Serum,
70 ul 80
Plasma CV(%)
Batch 7.6
Lot1
Temperature
7.9
Lot2 8.1
Detection Storage
Buffer: 2-8℃ Test Kit:
Kit: 2-30℃
2-30℃
Detection Buffer: 2-8℃
Sample
Sample Type AnyLab CV(%) Temperature Temperature Detection
Detection Buffer:
Buffer: 2-8℃
10 20 40 50 90 100
0
Type Serum,
Serum, Plasma
Plasma 6.04
6.2 5.91
6.1 5.66
5.7 Temperature 2-8℃
00 5 20 10 40 60 80 100 AnyLab CV(%) Temperature
5.9 6.1 5.8
0
Sample 10,000
5,000 Type 15
15,000 Serum,
20
Roche e411(mlU/mL) Plasma25,000
25
20,000
30
Roche e411(ug/dL)
Roche e411(ng/mL)
Cobas e411(pg/mL)
ZZ Biotech
Biotech Inc. Inc.
Z Biotech
Pregestational
Cancer
Cardiac
Inflammation
Thyroid Hormone
Hormone
TSH
AFP
CK-MB
Beta-hCG
CRP
Free&T3hsCRP
Ferritin
both. both.
Important
Most measurement
liver function.
A key of Anthem
marker is abnormal
of found
iron-containing
Important in the
measurement heart
pregnancy
protein muscle.
in -> status,
theThe Once
asofpregnancy
component
is stored
function. damaged,
of pregnancy
The
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Z Biotech
Cardiac
CK-MB
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Pregestational
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2.16 37.7
3.34
Reaction
Sample Time
Volum 15
100min.
ul
60
AnyLab CV(%)
F1(ng/mL)
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Sample Type Serum,
100 ul Plasma
Free T4
Prolactin
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ZZ Biotech
Biotech Inc. Inc.
Z Biotech
Pregestational
Cancer
Cardiac
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Thyroid Hormone
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3rd party Detection
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Time 31 --min.
30,000
100 mlU/mL
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Performance
AnyLab CV(%) 2.81 16.8
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7.3 Performance
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Anylab F1(mlU/mL)
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ZZ Biotech
Biotech Inc. Inc.
Z Biotech
Pregestational
Cancer
Cardiac
Inflammation
Thyroid Hormone
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TSH
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CK-MB
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liver function.
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marker is abnormal
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pregnancy
protein muscle.
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3rd party Detection
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Free T4 Sample Type
Volum Serum,
100 ul Plasma
F1(ng/mL)
50
Patient
F1(pg/mL)
6.12 18.01
Anylab
15,000
40
Sample
Product
Type
Type Serum,
Serum, Plasma
25 TestPlasma
Kit
Concentration
5.7
0.45 12.3
4.41 20.8
13.8
Detection
25
0.1
0.1 -- 8.0
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4,327 Kit
Anylab
Range ng/mL Product

Detection Buffer
Composition 25Test
25 Detection
Kit Buffer
Anylab
20
30
ReactionRange
Time 0.115- 100
5.69
6.6
Product 6.15
5.9 25
5.74
Buffer 25 Test Kit
Anylab
10,000
25 Kit Composition
Detection
25
25 Detection
Detection Buffer
20
Detection Buffer
1 C-card Buffer
SampleTime
Batch(10.0Lot2
Lot1 ug/dL) Lot3
1Test Kit: 2-30℃
10
1Test
C-card C-card
5
5,000 Sample Volum
Sample Volum 100
AnyLab Storage
Lot1
TemperatureLot2
Lot3 Kit: 2-30℃
Test
Lot3
Detection Storage
Buffer: 2-8℃ Test
Sample
Sample Type
30 Volum 60 200
Serum,
70 ul 80
Plasma CV(%)
Batch 7.6
Lot1
Temperature
7.9
Lot2 8.1
Detection Storage
Kit: 2-30℃
2-30℃
Sample
Detection Buffer:
Buffer: 2-8℃
10 20 40 50 90 100
0
Type Serum,
Serum, Plasma
Plasma 6.04
6.2 5.91
6.1 5.66
5.9 6.1 5.8
0
Sample 10,000
5,000 Type 15
15,000 Serum,
20
25
20,000
30
Roche e411(ug/dL)
Roche e411(ng/mL)
Cobas e411(pg/mL)
ZZ Biotech
Biotech Inc. Inc.
Z Biotech
Pregestational
Cancer
Cardiac
Inflammation
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AFP
CK-MB
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Time 31 --min.
30,000
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Performance
AnyLab CV(%) 2.81 16.8
5.9 Concentration
9.3 6.8
7.3 Performance
93.9
6.453.4
6.1 Reaction412
Reaction Time
Time 15 min.
15 min.
F1(ulU/mL)
80 600
300 R²= 0.997 139
Anylab F1(mlU/mL)
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Sample Volum 200

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Anylab F1(mlU/mL)
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0.8667
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7.0 6.1
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Anylab
Anylab
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Sample
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40 AnyLab CV(%) 4.7
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6.1 132.0
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Composition
Samples(ng/mL)
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AnyLab CV(%)
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Sample Type Serum,
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F1(ng/mL)
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6 8.1 9.3 8.9
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40
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60
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6
SampleVolum 100 ul
20
F1(ug/dL)
AnyLab
AnyLab FF TnI
Free T4 Sample Type
Volum Serum,
100 ul Plasma
F1(ng/mL)
50
Patient
F1(pg/mL)
6.12 18.01
Anylab
15,000
40
Sample
Product
Type
Type Serum,
Serum, Plasma
25 TestPlasma
Kit
Concentration
5.7
0.45 12.3
4.41 20.8
13.8
Detection
25
0.1
0.1 -- 8.0
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4,327 Kit
Anylab
Range ng/mL Product

Detection Buffer
Composition 25Test
25 Detection
Kit Buffer
Anylab
20
30
ReactionRange
Time 0.115- 100
5.69
6.6
Product 6.15
5.9 25
5.74
Buffer 25 Test Kit
Anylab
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25 Detection
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AnyLab Storage
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TemperatureLot2
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Sample
Sample Type
30 Volum 60 200
Serum,
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Batch 7.6
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7.9
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2-30℃
Sample
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Buffer: 2-8℃
10 20 40 50 90 100
0
Type Serum,
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Plasma 6.04
6.2 5.91
6.1 5.66
5.9 6.1 5.8
0
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5,000 Type 15
15,000 Serum,
20
25
20,000
30
Roche e411(ug/dL)
Roche e411(ng/mL)
Cobas e411(pg/mL)
ZZ Biotech
Biotech Inc. Inc.
Z Biotech

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2018.

01 Registration for Domestic market CRP and PCT in Korea(KFDA)

2014. 12 Foundation customized business (Foundation Promotion Center)

2014. 06 Acquisition of a licence for manufacturing medical equipments (MFDS, KFDA)

ANYLAB-F1 is a POCT (Point Of Care Test) system

In addition, the system has used the immuno-

RM472, E-9 Bldg., Chungdae-Street No.1, Seowon-District,

Sample Volum 200

300 AnyLab CV(%)

50 10 BatchBatch Lot1 Lot2 Lot3 Storage Test Kit: 2-30℃

150 5.9 6.4 5.7

5 5.51 4.54 4.53

100 352 987 2,314 Sample Type

3rd party 0.313

6.9 5.6 5.2

Egg stimulation hormone 21.4 57.3 123.2

Range ng/mL Product

Sample Volum 200

300 AnyLab CV(%)

50 10 BatchBatch Lot1 Lot2 Lot3 Storage Test Kit: 2-30℃

150 5.9 6.4 5.7

5 5.51 4.54 4.53

100 352 987 2,314 Sample Type

3rd party 0.313

6.9 5.6 5.2

Egg stimulation hormone 21.4 57.3 123.2

Range ng/mL Product

Sample Volum 100 ul

Roche Cobas e 411(ng/mL)

5.9 6.4 5.7

15,000 Patient Samples(pg/mL)

Sample Volum 200

300 AnyLab CV(%)

50 10 BatchBatch Lot1 Lot2 Lot3 Storage Test Kit: 2-30℃

150 5.9 6.4 5.7

5 5.51 4.54 4.53

100 352 987 2,314 Sample Type

3rd party 0.313

6.9 5.6 5.2

Egg stimulation hormone 21.4 57.3 123.2

Range ng/mL Product

Sample Volum 200

300 AnyLab CV(%)

50 10 BatchBatch Lot1 Lot2 Lot3 Storage Test Kit: 2-30℃

150 5.9 6.4 5.7

5 5.51 4.54 4.53

100 352 987 2,314 Sample Type

3rd party 0.313

6.9 5.6 5.2

Egg stimulation hormone 21.4 57.3 123.2

Range ng/mL Product

Sample Volum 200

300 AnyLab CV(%)

50 10 BatchBatch Lot1 Lot2 Lot3 Storage Test Kit: 2-30℃

150 5.9 6.4 5.7

5 5.51 4.54 4.53

100 352 987 2,314 Sample Type

3rd party 0.313

6.9 5.6 5.2

Egg stimulation hormone 21.4 57.3 123.2

Range ng/mL Product

Sample Volum 200

300 AnyLab CV(%)

50 10 BatchBatch Lot1 Lot2 Lot3 Storage Test Kit: 2-30℃