CHEM-CONTROL N (NORMAL) CHEM-CONTROL N (NORMAL)

LOT NUMBER / Lot No: 2230019 CONN-3030

Enzymes / Enzimler EXPIRY DATE / Miat : 06/23
CODE. / INSTRUMENT VALUE UNITS Serum control multicomponent for clinical chemistry assays. For in vitro diagnostic use only.
Component / İçerik Method / Metod RANGE / Aralık
Kod Cihaz Değer Birim
PRODUCT CHARACTERISTICS
bt 35i /Biotecnica 125,0 U/L 102,5 – 147,5 Control serum NORMAL is a human lyophilised serum.
ALP / Alkaline Phosphatase bt products With most constituent concentrations and activities in the normal range. Is intended for control of accuracy for use with manual and automated analytical procedures.
DEA / DGKC
ALP-10 Mindray BS series 122,0 U/L 100,0 – 144,0
(ALKALEN FOSFATAZ) REAGENTS
PKL125/BT 125 122,1 U/L 100,1 – 144,1 Human serum. Biological additives. Bacteriostatics agents.
The concentration / activities of the components are lot-specific. The exact values and ranges valid for reagents are given informational purpose in the value sheet. Each
bt 35i /Biotecnica 47,5 U/L 39,0 – 56,1 laboratory should establish their own reference ranges.

bt products PRECAUTIONS
ALT / GPT IFCC Mindray BS series 49,5 U/L 40,6 – 58,4
GPT-11 Components from human origin have been tested and found negative for the presence of HBsAg, HCV and antibody to HIV (1/2). However handle cautiously as
potentially infectious.
PKL125/BT 125 49,9 U/L 40,9 – 58,9
PREPARATION
bt 35i /Biotecnica 52,0 U/L 42,6 – 61,4 - Reconstitute (→) add 1 vial of distilled water (5.0mL) into the 1 vial of Control.
AMYLASE GAL-G2-CNP bt products - Mix thoroughly, avoiding foam forming.
Liquid/ Likit AMY-10 Mindray BS series 52,1 U/L 42,7 – 61,5 - Bring to room temperature for about 30 min. before use.
(AMİLAZ) Improper handing and/or storage can affect results.
PKL125/BT 125 51,8 U/L 42,5 – 61,1 Inaccurate reconstitution and errors in assay technique can cause erroneous results.

bt 35i /Biotecnica 47,2 U/L 38,7 – 55,7 STORAGE AND STABILITY

The Control serum is stable until the expiration date on the label when stored tightly closed at 2-8ºC and contaminations are prevented during their use. Do not use
bt products reagents over the expiration date or if there is visible evidence of microbial grown. Store tightly capped when not use.
AST / GOT IFCC
GOT-11 Mindray BS series 47,4 U/L 38,9 – 55,9

PKL125/BT 125 45,3 U/L 37,1 – 53,5

bt 35i /Biotecnica 4498 U/L 3695 – 5301 Klinik kimya çalışmaları için çok bileşenli kontrol serumu. Yalnız in vitro diagnostik kullanım içindir.
CHOLINESTARESE Butyrylthiocholine bt products
Bütiriltiokolin CHE-20 Mindray BS series 4685 U/L 3849 – 5521 ÜRÜN ÖZELLİKLERİ
(KOLİNESTERAZ) Kontrol serumu NORMAL liyofilize insan serumudur.
PKL125/BT 125 4534 U/L 3725 – 5343 İçerik konsantrasyon ve aktiviteleri normal sınırlar içerisindedir. Kullanım amacı, manuel yada otomatik analitik prosedürleri doğrulamak içindir.

bt 35i /Biotecnica 99,3 U/L 81,6 – 117 REAKTIFLER

İnsan Serumu. Biyolojik katkılar içerir. Bakteriostatik ajanlar mevcuttur. Bileşenin konsantrasyonu / aktivitesi üretildiği lota spesifiktir. Kesin değerler ve sınır aralıkları
bt products (range) değer tablosunda bilgi amaçlı olarak verilmiştir. Her laboratuvar kendi değer aralıklarını belirlemelidir.
CK-NAC DGKC / IFCC
CK-10 Mindray BS series 100,3 U/L 82,4 – 118
ÖNLEMLER
PKL125/BT 125 94,6 U/L 77,7 – 111
Bileşenler insan orijinli olup HBsAg, HCV ve HIV (1/2), için test edilmiş ve negatif bulunmuştur. Buna rağmen potansiyel olarak hastalıklı kabul edilmeli ve dikkatli
kullanılmalıdır.
bt 35i /Biotecnica 38,7 U/L 31,7 – 45,7
𝛶-GT bt products HAZIRLAMA
Szasz / IFCC
GGT-10 Mindray BS series 38,1 U/L 31,2 – 45,0 - Yeniden yapılandırma (→) 1 şişe kontrol şişesi içerisine 1 şişe (5.0 mL) distile su ilave edin.
(GAMMA GT) - Döndürerek çözün, köpürtmekten kaçının.
PKL125/BT 125 37,6 U/L 30,8 – 44,4 - Kullanmadan önce oda ısısına ulaşması için 30 dk. bekletin.
Uygunsuz taşıma ve depolama sonuçları etkileyebilir.
bt 35i /Biotecnica 297 U/L 243 – 351 Hatalı yeniden yapılandırma işlemi ile test tekniğindeki hatalar yanlış sonuçlara sebep olabilir.

bt products DEPOLAMA VE STABİLİTE

LDH-P SFBC / DGKC
LDH-30 Mindray BS series 301 U/L 246 – 356
Kontrol serumu 2-8ºC de etiket üzerindeki son kullanma tarihine kadar stabildir. Kullanım sırasında kontaminasyon oluşmasından kaçınılmalıdır. Son kullanım tarihi
biten yada üzerinde görünür mikrobiyal oluşum olan reaktifleri kullanmayınız. Kullanmadığınız zamanlarda kapağın sıkıca kapalı olmasına özen gösteriniz.
PKL125/BT 125 300 U/L 245 – 354

bt 35i /Biotecnica 58,9 U/L 48,2 – 69,6 Stability of the reconstituted Components Storage time and temperature
LIPASE Colorimetric bt products Yeniden yapılandırma sonrası stabilite Bileşenlerin sıcaklığa göre depolama süresi
Kolorimetrik LIP-20 Mindray BS series 57,2 U/L 46,8 – 67,6
(LİPAZ)
PKL125/BT 125 54,3 U/L 44,5 – 64,1 15 – 25 °C = 12 hours /12 saat
All components except for the following / Aşağıdakiler dışında tüm bileşenler
2 – 8 °C = 5 days / 5 gün
(T.and D Bilirubin, ACP, ACP-P , UIBC )
(-25) –( -15) °C = 4 weeks/ 4 hafta

15 – 25 °C = 2 hours/ 2 saat
Bilirubin 2 – 8 °C = 6 hours / 6 saat
(-25) –( -15) °C = 2 weeks/ 2 hafta

LOT NUMBER / Lot No: 2230019

EXPIRY DATE / Miat : 06/23
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LOT NUMBER / Lot No: 2230019

CHEM-CONTROL N (NORMAL)
EXPIRY DATE / Miat : 06/23 CONN-3030
Substrates / Substratlar Substrates / Substratlar
CODE. / INSTRUMENT VALUE UNITS CODE. / INSTRUMENT VALUE UNITS
Component / İçerik Method / Metod RANGE / Aralık Component / İçerik Method / Metod RANGE / Aralık
Kod Cihaz Değer Birim Kod Cihaz Değer Birim

1,02 mg/dL 0,84 – 1,20 0,75 mg/dL 0,62 – 0,89

bt 35i /Biotecnica bt 35i /Biotecnica
90,2 µmol/L 73,9 – 106 12,8 µmol/L 10,5 – 15,1

Jaffé without
bt products
1,05 mg/dL 0,86 – 1,24 bt products
0,68 mg/dL 0,56 – 0,80
Jendrassik-Grof / DMSO
deproteinization Mindray BS series Mindray BS series
CRE-11 (4R1+1R2) BIT-10
Deproteinizasyonsuz Jaffe 92,8 µmol/L 76,1 – 110 11,6 µmol/L 9,5 – 13,7

1,01 mg/dL 0,83 – 1,19 0,70 mg/dL 0,57 – 0,83

PKL125/BT 125 PKL125/BT 125
CREATININE 89,3 µmol/L 73,2 – 105 BILIRUBIN, TOTAL 12,0 µmol/L 9,8 – 14,1
(KREATİNİN) 1,01 mg/dL 0,83 – 1,19
(TOTAL BİLİRUBİN) 0,62 mg/dL 0,51 – 0,73
bt 35i /Biotecnica bt 35i /Biotecnica
89,3 µmol/L 73,2 – 105 10,6 µmol/L 8,7 – 12,5

bt products
0,91 mg/dL 0,75 – 1,07 bt products
0,68 mg/dL 0,56 – 0,80
Enzymatic PAP method
Mindray BS series Vanadate Mindray BS series
Enzimatik PAP metot CRE-10 BIT-10
80,4 µmol/L 66,0 – 95 11,6 µmol/L 9,5 – 13,7

0,91 mg/dL 0,75 – 1,07 0,64 mg/dL 0,52 – 0,76

PKL125/BT 125 PKL125/BT 125
80,4 µmol/L 66,0 – 95 10,9 µmol/L 9,0 – 12,9

98,4 mg/dL 83,6 – 113 0,20 mg/dL 0,15 – 0,25

bt 35i /Biotecnica bt 35i /Biotecnica
5,46 mmol/L 4,64 – 6,28 3,42 µmol/L 2,57 – 4,28

GLUCOSE bt products
98,3 mg/dL 83,6 – 113 bt products
0,19 mg/dL 0,14 – 0,24
Jendrassik-Grof / DMSO
GOD-PAP (Trinder) Mindray BS series Mindray BS series
(GLUKOZ) GLU-10
5,46 mmol/L 4,64 – 6,27
(4R1+1R2) BIT-10
3,25 µmol/L 2,44 – 4,06

97,4 mg/dL 82,8 – 112 0,19 mg/dL 0,14 – 0,24

PKL125/BT 125 PKL125/BT 125
5,41 mmol/L 4,59 – 6,22 BILIRUBIN, DIRECT 3,25 µmol/L 2,44 – 4,06

36,1 mg/dL 30,7 – 41,5

(DİREKT BİLİRUBİN) 0,65 mg/dL 0,49 – 0,81
bt 35i /Biotecnica bt 35i /Biotecnica
6,01 mmol/L 5,11 – 6,91 11,12 µmol/L 8,34 – 13,9

UREA bt products
34,1 mg/dL 29,0 – 39,2 bt products
0,35 mg/dL 0,26 – 0,44
Urease-GLDH UV
Mindray BS series Vanadate Mindray BS series
(ÜRE) Üreaz - GLDH UV URE-11 BID-10
5,68 mmol/L 4,83 – 6,53 5,99 µmol/L 4,49 – 7,5

34,5 mg/dL 29,3 – 39,7 0,36 mg/dL 0,27 – 0,45

PKL125/BT 125 PKL125/BT 125
5,74 mmol/L 4,88 – 6,61 6,16 µmol/L 4,62 – 7,7

3,45 mg/dL 2,94 – 3,96

bt 35i /Biotecnica
205 µmol/L 175 – 236

URIC ACID bt products

3,63 mg/dL 3,09 – 4,17
Uricase-PAP
Mindray BS series
(ÜRİK ASİT) Ürikaz-PAP URI-10
216 µmol/L 184 – 248

3,38 mg/dL 2,88 – 3,88

PKL125/BT 125
201 µmol/L 171 – 231

LOT NUMBER / Lot No: 2230019

EXPIRY DATE / Miat : 06/23
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LOT NUMBER / Lot No: 2230019

CHEM-CONTROL N (NORMAL)
EXPIRY DATE / Miat : 06/23 CONN-3030
Lipids / Lipidler Proteins / Proteinler
CODE. / INSTRUMENT VALUE UNITS CODE. / INSTRUMENT VALUE UNITS
Component / İçerik Method / Metod RANGE / Aralık Component / İçerik Method / Metod RANGE / Aralık
Kod Cihaz Değer Birim Kod Cihaz Değer Birim
90,1 mg/dL 76,8 – 103 5,10 g/dL 4,47 – 5,73
bt 35i /Biotecnica bt 35i /Biotecnica
2,32 mmol/L 1,98 – 2,67 51,0 g/L 44,7 – 57,3

TOTAL CHOLESTEROL bt products

90,7 mg/dL 77,3 – 104 TOTAL PROTEIN bt products
5,17 g/dL 4,53 – 5,81
CHOD-PAP Mindray BS series Biuret / Biüret Mindray BS series
(TOTAL KOLESTEROL) CHO-10
2,34 mmol/L 1,99 – 2,69
(TOTAL PROTEİN) PRO-10
51,7 g/L 45,3 – 58,1

90,8 mg/dL 77,4 – 104 5,11 g/dL 4,48 – 5,74

PKL125/BT 125 PKL125/BT 125
2,34 mmol/L 2,00 – 2,69 51,1 g/L 44,8 – 57,4

32,1 mg/dL 24,1 – 40,1 3,32 g/dL 2,73 – 3,91

bt 35i /Biotecnica bt 35i /Biotecnica
0,83 mmol/L 0,62 – 1,04 33,2 g/L 27,3 – 39,1

HDL CHOLESTEROL bt products

33,4 mg/dL 25,1 – 41,8 ALBUMIN bt products
3,36 g/dL 2,76 – 3,96
Direct method- PVS/PEGME Bromocresol green
Mindray BS series Mindray BS series
(HDL KOLESTEROL) Direkt metot- PVS/PEGME HDL-50 (ALBÜMİN) Bromkresol yeşili ALB-10
0,87 mmol/L 0,65 – 1,08 33,6 g/L 27,6 – 39,6

33,6 mg/dL 25,2 – 42,0 3,37 g/dL 2,77 – 3,97

PKL125/BT 125 PKL125/BT 125
0,87 mmol/L 0,65 – 1,09 33,7 g/L 27,7 – 39,7

40,5 mg/dL 32,4 – 48,6

bt 35i /Biotecnica
1,05 mmol/L 0,84 – 1,26

LDL CHOLESTEROL Direct method- PVS/PEGME bt products

41,9 mg/dL 33,5 – 50,3 Electrolytes / Elektrolidler
Mindray BS series
(LDL KOLESTEROL) Direkt metot- PVS/PEGME LDL-50 CODE. / VALUE UNITS
1,09 mmol/L 0,87 – 1,30 Component / İçerik Method / Metod Kod Değer Birim
RANGE / Aralık

39,1 mg/dL 31,3 – 46,9 8,39 mg/dL 7,35 – 9,43

PKL125/BT 125 bt 35i /Biotecnica
1,01 mmol/L 0,81 – 1,22 2,10 mmol/L 1,84 – 2,36

89,3 mg/dL 75,2 – 103 CALCIUM (Ca) bt products

8,43 mg/dL 7,39 – 9,47
bt 35i /Biotecnica Arsenazo III Mindray BS series
1,01 mmol/L 0,85 – 1,17
(KALSİYUM) CAL-10
2,11 mmol/L 1,85 – 2,37

TRIGLYCERIDES bt products
89,7 mg/dL 75,5 – 104 8,40 mg/dL 7,36 – 9,44
GPO-PAP Mindray BS series PKL125/BT 125
(TRİGLİSERİD) TRI-10
1,01 mmol/L 0,85 – 1,17 2,10 mmol/L 1,84 – 2,36

88,4 mg/dL 74,4 – 102 bt products

88,3 mmol/L* 80,4 – 96,2
ISE Direct Potentiometric
PKL125/BT 125 bt 35i /Biotecnica
ISE Direkt Potansiyometrik ISE-10300
1,00 mmol/L 0,84 – 1,16 313 mg/dL 285 – 342

bt products
88,3 mmol/L* 80,4 – 96,2
bt 35i /Biotecnica
ISE-10160
LOT NUMBER / Lot No: 2230019 313 mg/dL 285 – 342
ISE Indirect Potentiometric
ISE İndirekt Potansiyometrik
EXPIRY DATE / Miat : 06/23 CHLORIDE (Cl) bt products
87,1 mmol/L* 79,3 – 94,9
Mindray BS series
(KLORÜR) ISE-102000M
309 mg/dL 281 – 337

82,4 mmol/L* 75,0 – 89,8

bt 35i /Biotecnica
bt products
292 mg/dL 266 – 319
Colorimetric / Kolorimetrik
CHL-10
77,7 mmol/L* 70,7 – 84,7
PKL125/BT 125
276 mg/dL 251 – 301

* mmol/L= mEq/L
 LOT NUMBER / Lot No: 2230019
CHEM-CONTROL N (NORMAL)
EXPIRY DATE / Miat : 06/23 CONN-3030
Electrolytes / Elektrolidler Electrolytes / Elektrolidler
CODE. / INSTRUMENT VALUE UNITS CODE. / INSTRUMENT VALUE UNITS
Component / İçerik Method / Metod RANGE / Aralık Component / İçerik Method / Metod RANGE / Aralık
Kod Cihaz Değer Birim Kod Cihaz Değer Birim
79,1 µg/dL 63,3 – 94,9 bt products
108 mmol/L* 86,4 – 130
ISE Direct Potentiometric
bt 35i /Biotecnica bt 35i /Biotecnica
ISE Direkt Potansiyometrik ISE-10300
12,4 µmol/L 9,9 – 14,9 248 mg/dL 199 – 298

COPPER (Cu) bt products

82,9 µg/dL 66,3 – 99,5 bt products
108 mmol/L* 86,4 – 130
Colorimetric 3,5-diBr-PAESA
Mindray BS series bt 35i /Biotecnica
(BAKIR) Kolorimetrik, 3,5-diBr-PAESA COP-20 ISE-10160
13,0 µmol/L 10,4 – 15,6 248 mg/dL 199 – 298
ISE Indirect Potentiometric
ISE İndirekt Potansiyometrik
74,6 µg/dL 59,7 – 89,5 SODIUM (Na) bt products
121 mmol/L* 96,8 – 145
PKL125/BT 125 Mindray BS series
11,7 µmol/L 9,4 – 14,1
(SODYUM) ISE-102000M
278 mg/dL 222 – 334

116,5 µg/dL 96,3 – 137 111,6 mmol/L* 89,3 – 134

bt 35i /Biotecnica bt 35i /Biotecnica
20,9 µmol/L 17,2 – 24,4 bt products
256 mg/dL 205 – 308
Enzymatic / Enzimatik
SOD-10
IRON (Fe) bt products
105 µg/dL 86,8 – 123 108 mmol/L* 86,4 – 130
Ferrozine/ Ferene
Mindray BS series PKL125/BT 125
(DEMİR) Ferrozin/ Ferene IRO-10
18,8 µmol/L 15,5 – 22,0 248 mg/dL 199 – 298

104,9 µg/dL 86,8 – 123 181 µg/dL 137 – 225

PKL125/BT 125 bt 35i /Biotecnica
18,8 µmol/L 15,5 – 22,0 32,4 µmol/L 24,6 – 40,2

2,20 mg/dL 1,94 – 2,46 UIBC bt products

181 µg/dL 137 – 225
Ferrozine/ Ferene
bt 35i /Biotecnica Mindray BS series
Unsaturated Iron Binding Capacity Ferrozin/ Ferene UIBC-50
0,91 mmol/L 0,80 – 1,02 32,4 µmol/L 24,6 – 40,2
(Doymamış demir bağlama kapasitesi)
MAGNESIUM (Mg) bt products
2,20 mg/dL 1,94 – 2,46 177 µg/dL 134 – 220
Xylidyl Blue Mindray BS series PKL125/BT 125
(MAGNESYUM) MAG-50
0,91 mmol/L 0,80 – 1,02 31,7 µmol/L 24,0 – 39,3

2,17 mg/dL 1,91 – 2,43 298 µg/dL 226 – 369

PKL125/BT 125 bt 35i /Biotecnica
0,89 mmol/L 0,79 – 1,00 53,3 µmol/L 40,4 – 66,1

4,12 mg/dL 3,46 – 4,78 TIBC bt products

286 µg/dL 217 – 355
Ferrozine/ Ferene
bt 35i /Biotecnica Mindray BS series
Total Iron Binding Capacity Ferrozin/ Ferene TIBC-50
1,33 mmol/L 1,12 – 1,54 51,2 µmol/L 38,9 – 63,5
(Total Demir Bağlama Kapasitesi)
PHOSPHORUS,INORGANIC (P) bt products
4,15 mg/dL 3,49 – 4,81 281,7 µg/dL 214 – 350
Phosphomolybdate-UV
Mindray BS series PKL125/BT 125
(FOSFOR, İNORGANİK) Fosfomolibdat -UV PHO-10
1,34 mmol/L 1,13 – 1,55 50,4 µmol/L 38,3 – 62,6

4,15 mg/dL 3,49 – 4,81 234 µg/dL 199 – 269

PKL125/BT 125 bt 35i /Biotecnica
1,34 mmol/L 1,13 – 1,55 35,8 µmol/L 30,4 – 41,2

bt products
3,00 mmol/L* 2,40 – 3,60 ZINC bt products
256 µg/dL 218 – 294
ISE Direct Potentiometric Colorimetric 5-Br PAPS
bt 35i /Biotecnica Mindray BS series
ISE Direkt Potansiyometrik ISE-10300 (ÇİNKO) Kolorimetrik, 5-Br PAPS ZIN-20
11,8 mg/dL 9,41 – 14,11 39,2 µmol/L 33,3 – 45,0

bt products
3,00 mmol/L* 2,25 – 3,75 255 µg/dL 217 – 293
bt 35i /Biotecnica PKL125/BT 125
ISE-10160
11,8 mg/dL 8,8 – 14,7 39,0 µmol/L 33,2 – 44,9
ISE Indirect Potentiometric
ISE İndirekt Potansiyometrik
POTASSIUM (K) bt products
3,40 mmol/L* 2,55 – 4,25 * mmol/L= mEq/L
Mindray BS series
(POTASYUM) ISE-102000M
13,3 mg/dL 10,0 – 16,7

3,49 mmol/L* 2,62 – 4,36

bt 35i /Biotecnica
bt products
13,7 mg/dL 10,3 – 17,1
Enzymatic / Enzimatik
POT-10
3,28 mmol/L* 2,46 – 4,10
PKL125/BT 125
12,9 mg/dL 9,6 – 16,1

LOT NUMBER / Lot No: 2230019 * mmol/L= mEq/L

EXPIRY DATE / Miat : 06/23 Form Rev. Tarih/Date No: 07.02.2022/8