J.T.Bakers' products for Histology and Cytology vegyszer/Product... · CE marked All staining...
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INTRODUCTION FIXATIVES PARAFFIN STAINS AND DYES CLEARING DECALCIFIER SOLVENTS CLEANERS Introduction The chemical know-how of Mallinckrodt Baker and our manufacturing and purification competencies form the basis of a comprehensive range of chemicals, stains and auxiliary products. Especially formulated and purified for use in the Histo-pathology. Together with our environmentally and human friendly clearing reagents, a range of solvents, alcohols, fixatives, stains and dyes are available through our network of international distributors. Production The reagents are produced using state-of-the-art production techniques in modern, certified manufactu- ring facilities, to assure a minimum of impurities. Production is centralised at the Mallinckrodt Baker head-office in the town of Deventer, the Netherlands. Our commitment to the International Responsible Care program is contributing to environmental friendly and efficient manufacturing. The high quality water and solvents manufactured by Mallinckrodt Baker guaran- tee the quality of the solutions produced. The products are bottled under controlled conditions to prevent contamination and degradation, thus assuring maximum stability. Quality Control Every batch of a reagent is use-tested and released in accordance with ISO-9001 regulations. A highly educated staff of specialists, working in a well- equipped R&D and QC laboratory, guarantees lot-to-lot consistency and provides technical customer support. ISO 9001 Mallinckrodt Bakers’ ongoing pursuit of Total Quality has resulted in a NEN-EN-ISO 9001:2000 certified quality system for Mallinckrodt Baker Europe. The certification includes design, development, production and supply of the products. ISO 14001 Since January 2004 Mallinckrodt Baker is also NEN-EN-ISO 14001:1996 certified. ISO 14001 is ISO’s environmental manage- ment system that describes the efforts taken to minimize harmful effects to the environ- ment. CE Mark, European IVD Directive 98/79/EC From June 2000 In Vitro Diagnostic Medical Devices (IVDs), sold in the European market, have to be in compliance with the IVD Directive 98/79/EC and have to show the CE mark when the registration is completed. The transition period ended in December 2003. For Mallinckrodt Baker this means that several histopathology products are CE marked. Mallinckrodt Baker has completed the technical dossiers of the histopathology products and has registered these products at the competent authorities of the countries that require such registration. What does this mean for the products? There is no difference in quality. All products are produced in the same way as before, QC tested and packed as before and guaranteed as before. What’s the difference? CE marking requires some additional information on the label. Symbols instead of text will be used to express some data: IVD For in vitro diagnostic use Expiry date: month-year 30°C Store and use at room 18 ° C temperature Manufactured by CE registered product REF Product Number LOT Lot Number: yyddd12345 yy :year of production ddd :day of production 12345 :production number If and where possible the product description will be printed in 8 languages. ▼ Example of the label J.T.Bakers’ products for Histology and Cytology 3
Transcript of J.T.Bakers' products for Histology and Cytology vegyszer/Product... · CE marked All staining...
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IntroductionThe chemical know-how of Mallinckrodt Baker and our manufacturing and purifi cation competencies form the basis of a comprehensive range of chemicals, stains and auxiliary products. Especially formulated and purifi ed for use in the Histo-pathology. Together with our environmentally and human friendly clearing reagents, a range of solvents, alcohols, fi xatives, stains and dyes are available through our network of international distributors.
ProductionThe reagents are produced using state-of-the-art production techniques in modern, certifi ed manufactu-ring facilities, to assure a minimum of impurities. Production is centralised at the Mallinckrodt Baker head-offi ce in the town of Deventer, the Netherlands. Our commitment to the International Responsible Care program is contributing to environmental friendly and effi cient manufacturing. The high quality water and solvents manufactured by Mallinckrodt Baker guaran-tee the quality of the solutions produced. The products are bottled under controlled conditions to prevent contamination and degradation, thus assuring maximum stability.
Quality ControlEvery batch of a reagent is use-tested and released in accordance with ISO-9001 regulations. A highly educated staff of specialists, working in a well-equipped R&D and QC laboratory, guarantees lot-to-lot consistency and provides technical customer support.
ISO 9001 Mallinckrodt Bakers’ ongoing pursuit of Total Quality has resulted in a NEN-EN-ISO 9001:2000 certifi ed quality system for Mallinckrodt Baker Europe. The certifi cation includes design, development, production and supply of the products.
ISO 14001 Since January 2004 Mallinckrodt Baker is also NEN-EN-ISO 14001:1996 certifi ed. ISO 14001 is ISO’s environmental manage-ment system that describes the efforts taken to minimize harmful effects to the environ-ment.
CE Mark , European IVD Directive 98/79/ECFrom June 2000 In Vitro Diagnostic Medical Devices (IVDs), sold in the European market, have to be in compliance with the IVD Directive 98/79/EC and have to show the CE mark when the registration is completed. The transition period ended in December
2003. For Mallinckrodt Baker this means that several histopathology products are CE marked. Mallinckrodt Baker has completed the technical dossiers of the histopathology products and has registered these products at the competent authorities of the countries that require such registration.
What does this mean for the products?There is no difference in quality. All products are produced in the same way as before, QC tested and packed as before and guaranteed as before.
What’s the difference?CE marking requires some additional information on the label. Symbols instead of text will be used to express some data:
IVD For in vitro diagnostic use
Expiry date: month-year
30°C Store and use at room 18°C temperature
Manufactured by
CE registered product
REF Product Number
LOT Lot Number: yyddd12345
yy :year of productionddd :day of production12345 :production number
If and where possible the product description will be printed in 8 languages.
▼ Example of the label
J.T.Bakers’ products for Histology and Cytology
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CE markedAll staining solutions, ready-to-use fi xatives, UltraClear and UltraKitt are CE marked.
Declaration of ConformityFor tenders or for registration of the products it is sometimes required to show a declaration of confor-mity. This declaration is available on request.
DocumentationAll documentation is available free of charge. Our web site informs you in detail about our product program, advised protocols and trouble shooting information.
Visit: www.mallbaker.com
Declaration of CE conformity
Mallinckrodt Baker B.V., reg. No. 38013066 who is an established manufacturer of Hematology- Reagents, Stains, Controls and Calibrators and products for Histopathology located at:
Teugseweg 207418 AM Deventerthe Netherlands
herewith declares the following:
The Mallinckrodt Baker reagents (see attached list) are labeled with the J.T.Baker label and have the CE mark on the label where applicable. The devices comply with the In Vitro Diagnostic Medical Devices Directive 98/79/EC.The products are not part of List A and List B of Annex II of the IVD Directive 98/79/EC but are subject to self registration.This declaration is valid for all the IVD medical devices described above and which are placed on the market by ourselves on or after the date hereof and which bear the CE marking.
Deventer, The Netherlands.September, 2006
W. HusselmanManager Quality Assurance
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Product Product Number Content Packaging CE mark
Stains and Dyes
Eosin Solution 0.2% aqueous 3874.1000 1 liter Glass bottle CEEosin Solution 0.2% aqueous 3874.2500 2.5 liter Glass bottle CEEosin Solution 0.2% ready to use 3871.1000 1 liter Glass bottle CEEosin Solution 0.2% ready to use 3871.2500 2.5 liter Glass bottle CEGiemsa 3856.0100 100 ml Glass bottle CEGiemsa 3856.0500 0.5 liter Glass bottle CEGiemsa 3856.1000 1 liter Glass bottle CEGiemsa 3856.2500 2.5 liter Glass bottle CEGiemsa Stain, dry powder 3815.0025 25 g Glass jarHemacolour 3719.0300 300 ml Glass bottle CEHemacolour 3719.1000 1 liter Glass bottle CEHemacolour startset 3717 300 ml + jars + slides Glass bottleHematoxylin er (Mayer) 3870.1000 1 liter Glass bottle CEHematoxylin er (Mayer) 3870.2500 2.5 liter Glass bottle CEHematoxylin Modifi ed (Harris, Gill II) 3873.1000 1 liter Glass bottle CEHematoxylin Modifi ed (Harris, Gill II) 3873.2500 2.5 liter Glass bottle CELeishman 3879.1000 1 liter Glass bottle CELeishman 3879.2500 2.5 liter Glass bottle CELeishman Stain, dry powder 3813.0025 25 g Glass jarMay Grünwald 3855.0100 100 ml Glass bottle CEMay Grünwald 3855.0500 0.5 liter Glass bottle CEMay Grünwald 3855.1000 1 liter Glass bottle CEMay Grünwald 3855.2500 2.5 liter Glass bottle CEMay Grünwald Stain, dry powder 3814.0025 25 g Glass jarPapanicolaou 2A OG6 3864.1000 1 liter Glass bottle CEPapanicolaou 2A OG6 3864.2500 2.5 liter Glass bottle CEPapanicolaou 2B Orange II 3865.1000 1 liter Glass bottle CEPapanicolaou 2B Orange II 3865.2500 2,5 liter Glass bottle CEPapanicolaou 3B EA 50 3866.1000 1 liter Glass bottle CEPapanicolaou 3B EA 50 3866.2500 2.5 liter Glass bottle CEScotch buffer 3872.5000 5 liter CubitainerSorenson Buffer 20 x concentrated 3716 10 x 100 ml HDPE bottleWright 3878.1000 1 liter Glass bottle CEWright 3878.2500 2.5 liter Glass bottle CEWright Stain, dry powder 3816.0025 25 g Glass jar
Paraffi n
UltraPar (54-56°C) 3925.5000 5 kg PP drum
Clearing agents
MountingClear 3904.2500 2.5 liter Glass bottleUltraClear 3905.2500 2.5 liter Tin CEUltraClear 3905.5000 5 liter Tin CEUltraClear 3905.9010 10 liter Tin CEUltraClear 3905.9200 200 liter Steel drum CE
Mounting media
UltraKitt 3921.0500 500 ml Glass bottle CEUltraKitt 3921.0600 6 x 100 ml Glass bottle CE
J.T.Bakers’ product list for Histology/Cytology
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Product Product Number Content Packaging CE mark
Fixatives
Cervix Spray Fixative 3869.1200 12 x 125 ml Glass + spraycap CE10% v/v Buffered Formaldehyde (4% w/v) 3933.1000 1 liter HDPE* bottle CE10% v/v Buffered Formaldehyde (4% w/v) 3933.5000PC 5 liter Cubitainer CE10% v/v Buffered Formaldehyde (4% w/v) 3933.9010 10 liter Cubitainer CE10% v/v Buffered Formaldehyde (4% w/v) 3933.9010PE 10 liter Jerrycan CE10% v/v Buffered Formaldehyde (4% w/v) 3933.9020 20 liter Cubitainer CE10% v/v Buffered Formaldehyde (4% w/v) 3933.9020PE 20 liter Jerrycan CE10% v/v Buffered Formaldehyde (4% w/v) 3933.9200 200 liter HDPE drum CE19% g/v Buffered Formaldehyde 3858.9020 20 liter Jerrycan38% g/v Buffered Formaldehyde 3859.5000 5 liter Jerrycan38% g/v Buffered Formaldehyde 3859.9010 10 liter JerrycanFormalin Neutralizer 3934.5000 5 kg PP drumBouin’s Fixative 3880.1000 1 liter HDPE bottle CEDecalcifi er Rapid 3930.2500 2.5 liter HDPE bottle
Solvents
Acetone 3403.5000 5 liter HDPE canAcetone 3403.9010 10 liter HDPE canAcetone 3403.9025 25 liter HDPE canBenzylalcohol 3402.9025 25 liter HDPE canEthanol 96 % 3405.2500PE 2.5 liter HDPE bottleEthanol 96 % 3405.5000 5 liter HDPE canEthanol 96 % 3405.9010 10 liter HDPE canEthanol 96 % 3405.9025 25 liter HDPE canEthanol 96 % denatured with 5% Methanol 3407.5000 5 liter HDPE canEthanol 96 % denatured with 5% Methanol 3407.9010 10 liter HDPE canEthanol 96 % denatured with 5% Methanol 3407.9025 25 liter HDPE canEthanol 96 % denatured with 5% Methanol 3407.9200PE 200 liter HDPE drumEthanol 99 % 3406.2500PE 2.5 liter HDPE bottleEthanol 99 % 3406.5000 5 liter HDPE canEthanol 99 % 3406.9010 10 liter HDPE canEthanol 99 % 3406.9025 25 liter HDPE canEthanol 99 % denatured with 5% Methanol 3408.5000 5 liter HDPE canEthanol 99 % denatured with 5% Methanol 3408.9010 10 liter HDPE canEthanol 99 % denatured with 5% Methanol 3408.9025 25 liter HDPE canIsopropanol 3401.5000 5 liter HDPE canIsopropanol 3401.9010 10 liter HDPE canIsopropanol 3401.9025 25 liter HDPE canMethanol 3400.0500PE 0.5 liter HDPE bottleMethanol 3400.5000 5 liter HDPE canMethanol 3400.9010 10 liter HDPE canMethanol 3400.9025 25 liter HDPE canToluene 3411.9010 10 liter TinXylene 3410.2500PE 2.5 liter HDPEXylene 3410.5000PE 5 liter HDPE canXylene 3410.9010 10 liter TinXylene 3410.9025 25 liter Tin
Cleaners, others and accessories
Paraffi n Cleaner 3451.1500 12 x 125 ml HDPE bottleBaker-Clear 12 Lab Cleaner 7340.5000 5 liter HDPE canPump for UltraClear cans 4909 unitTap for Polycubes 3953 unitImmuno PBS 20x concentrated 3058.9010 10 liter Polycube CE* HDPE High Density Polyethylene
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J.T.Baker Product J.T.Baker
Number
E.Merck Product E.Merck Number
Stains and dyes
Eosin Solution 0.2% ready to use 3871 Not SuppliedEosin Solution 0.2% aqueous 3874 Not SuppliedGiemsa 3856 Giemsa’s Azur-Eosin-Methylenblaulösung,
modifi ziert109204
Giemsa Stain 3815 Giemsa’s Azur-Eosin-Methylenblau 109203Hemacolour 3719 Hemacolour Schnellfarbung von
Blutausstrichen:3x500ml111661
Hemacolour 3719 Hemacolour Schnellfarbung von Blutausstrichen, Reagenz 1+2+3
111955+111956+ 111957
Hemacolour Startset 3717 Not SuppliedHematoxylin modifi ed (Harris,Gill II, PAP1) 3873 Hämatoxylin-Lösung modifi ziert nach Gill
III105174
Hematoxylin modifi ed (Harris,Gill II, PAP1) 3873 Hämatoxylin-Lösung modifi ziert nach Gill II 105175
Hematoxylin modifi ed (Harris,Gill II, PAP1) 3873 Papanicolaous Lösung 1a Harris Hämatoxylin-Lösung
109253
Hematoxylin modifi ed (Harris,Gill II, PAP1) 3873 Papanicolaous Lösung 1b Harris Hämatoxylin-Lösung S
109254
Hematoxylin er (Mayer) 3870 Mayers Hämalaunlösung 109249Leishman 3879 Leisman’s Eosin-Methylenblaulösung,
modifi ziert105387
Leishman Stain 3813 Leisman’s Eosin-Methylenblau 101350May Grünwald 3855 May Grünwalds Eosin-
Methylenblaulösung, modifi ziert101424
May Grünwald Stain 3814 May Grünwalds Eosin-Methylenblau 101352Papanicolaou 2A OG6 3864 Papanicolaous Lösung 2a OG6 106888Papanicolaou 2B Orange II 3865 Papanicolaous Lösung 2b Orange II 106887Papanicolaou 3B EA 50 3866 Papanicolaous Lösung 3b Polychrom
lösung109272
Scotch buffer 3872 Not SuppliedSorenson Buffer 20 x concentrated 3716 Not SuppliedShorr 3786 Shorr’sche Farblösung 109275Wright 3878 Wrights Eosin-Methylenblaulösung 101383Wright Stain 3816 Wright’s Eosin-Methylenblau 109278
Clearing and mounting agents and Paraffi n
MountingClear 3904 Not SuppliedPump for UltraClear cans 4909 Not SuppliedUltraClear 3905 NeoClear 109843UltraKitt 3921 NeoMount 109016UltraPar (54–56) 3925 Histosec pastillen 111609
Fixatives
Cervix Spray Fixative 3869 Merckofi x Fixationsspray 10398110% v/v Buffered Formaldehyde (4% w/v) 3933 Formaldehyd Lösung 4%, pH 6.9 10049619% g/v Buffered Formaldehyde 3858 Formaldehyd Lösung min. 20% (not
buffered!)104025
38% g/v Buffered Formaldehyde 3859 Formaldehyd Lösung min. 35% (not buffered!)
104001
Bouin’s Fixative 3880 Not SuppliedFormalin Neutralizer 3934 Not SuppliedDecalcifi er Rapid 3930 Osteomoll 101736
Cross Reference list: J.T.Baker products versus E.Merck products
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J.T.Baker Product J.T.Baker
Number
E.Merck Product E.Merck Number
Solvents
Acetone 3403 Acetone PA / Acetone Ph Eur 100014 / 100013Benzylalcohol 3402 Benzyl Alcohol PA 109626Ethanol 96 % 3405 Ethanol 96% DAB 100971Ethanol 96 % denatured 3407 Not SuppliedEthanol 96% 3406 Ethanol 99% zur Synthese 818761Ethanol 99 % 3406 Ethanol 99% PA 100983Ethanol 99 % denatured 3408 Not SuppliedIsopropanol 3401 2-Propanol zur Synthese 818766Methanol 3400 Methanol zur Synthese 822283Toluene 3411 Toluol zur Synthese 818765Xylene 3410 Xylol zur Synthese 818754
Cleaners, others
Paraffi n Cleaner Paraffi n remover 3451 Not SuppliedBakerClear 12 Lab Cleaner 7340 Not SuppliedImmuno PBS 3058 Not Supplied
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