2010 Catalogue.pdf - Abacus ALS

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TECHNICAL INFORMATION BULLETIN TIB.081 Method 17 • Rehydrate 1 pellet of M. gallisepticum in SP4 Glucose Broth. Alternatively, inoculate broth with a KWIK- STIK. Make serial dilutions (for example, 1:2, 1:4). Incubate at 35°C in aerobic atmosphere. As soon as the broth turns from red to yellow (4 days to 2 weeks), sub 0.2 mL of broth to SP4 Glucose Agar and streak for isolation. DO NOT use cotton swab or wooden shaft. Incubate at 35°C in CO 2 atmosphere, preferably in a candle jar, for 3 days to 2 weeks. In order to see colonies, examine plates microscopically. Method 18 • Rehydrate 1 pellet of M. hyorhinis in SP4 Glucose Broth. Alternatively, inoculate broth with a KWIK-STIK. Make serial dilutions (for example, 1:10, 1:100, 1:1000). Incubate at 35°C in aerobic atmosphere. As soon as the broth turns from red to yellow (4 days to 2 weeks), sub 0.2 mL of broth to SP4 Glucose Agar and streak for isolation. DO NOT use cotton swab or wooden shaft. Incubate at 35°C in CO 2 atmosphere, preferably in a candle jar, for 2 to 10 days. In order to see colonies, examine plates microscopically. Method 19 • Rehydrate 1 pellet of M. synoviae in SP4 Glucose Broth. Alternatively, inoculate broth with a KWIK-STIK. Make serial dilutions (for example, 1:2, 1:4, 1:8, 1:16, 1:32). Incubate at 35°C in 5 to 10% CO2 for 7 days. After 7 days (no color change will be noted), sub 0.2 mL of broth to SP4 Glucose Agar and streak for isolation. DO NOT use cotton swab or wooden shaft. Incubate at 35°C in CO 2 atmosphere, preferably in a candle jar, for 1 to 4 weeks. In order to see colonies, examine plates microscopically. Method 20 • Chocolate agar, Sheep Blood Agar, Tryptic Soy Agar, Bordet Gengou Agar with 15% Defibrinated Sheep Blood - 35°C in aerobic atmosphere – 24 to 48 hours. Standard Methods (Plate Count Agar) or Nutrient Agar are appropriate alternatives together with an additional period (24 hours) of incubation. Method 21 • Chocolate or Bordet Gengou Agar with 15% Defibrinated Sheep Blood - 35°C in aerobic atmosphere – 2 days to one week. B. pertussis, MicroBioLogics #100, and B. pertussis, MicroBioLogics #0843, require Bordet Gengou Agar with 15% Defibrinated Sheep Blood. TIB.081 Revision 2010.FEB.19 Page 6 of 6 LIT.014 REVISION 2010.March.15 Microbiologics® Retail Products: 38th Edition Page 85
QUALITY POLICY AND QUALITY ASSURANCE Executive management at Microbiologics has established its policy and objectives for, and commitment to, quality and bears the ultimate responsibility for ensuring the quality of all products and services. This responsibility is extended to, and shared by, every employee contributing to quality products and service. Microbiologics Quality Policy Statement is “To ensure total customer satisfaction, Microbiologics provides services and products of defined, known, and defensible quality.” ATCC LICENSED DERIVATIVE ® PROGRAM Under the ATCC Licensed Derivative ® Program, in 2005, Microbiologics was the first manufacturer that signed the license agreement with ATCC ® . CE MARK The CE Mark is a regulatory directive to which the Microbiologics CE Marked products conform. The CE Mark provides testimony that the products meet the requirements of the “In Vitro Diagnostic Directive” and conform to criteria for placing in vitro diagnostic medical devices on the European Market. Any company or organization that markets, sells and distributes similar products into the European Market must conform with the CE Mark directive. Microbiologics conforms to the CE Mark requirements for its Reference Stock culture products including LYFO DISK ® , KWIK-STIK , and KWIK-STIK Plus Microorganisms, and for its slide product line consisting of Microbiology QC Slides and KWIK-QC Slides. The Enumerated Product Lines of Microbiologics that include Epower , EZ-Accu Shot, EZ-CFU , EZ-CFU One Step, EZ-FPC , EZ-PEC and EZ-SPORE microorganisms are intended for industrial applications only. Because the enumerated products are not intended for clinical applications and are not actually used for establishing or verifying performances of medical devices, they do not fall under the definition of “in vitro diagnostic medical devices” as defined in the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostics medical devices. Therefore, the requirements of this directive, including the CE Mark, do not apply to the above Microbiologics enumerated stated products. EXTERNAL AUDITS Microbiologics allows customers the opportunity to visit and audit its facilities during normal business hours to determine adherence to quality assurance programs, regulatory compliance, and conformity to international standards according to their Quality System Audit Policy, LIT.128. Said audit will not include access to proprietary information or plant areas that would breach the security and integrity of Microbiologics proprietary information and intellectual property. FOOD AND DRUG ADMINISTRATION ESTABLISHMENT Microbiologics is registered with the Food and Drug Administration (FDA) as a Device Establishment FDA Establishment # 2150138). This registration dictates regulatory mandates to meet and comply with the elements set forth in the FDA; Quality System Regulation (QSR) 21CFR Part 820 Medical Devices; Current Good Manufacturing Practice (CGMP). The compliance applies to the methods used in, and the facilities and controls used for, the design, purchase, manufacture, packaging, labeling, storage, and distribution of in-vitro, medical diagnostic products. These provisions are intended to ensure that finished product will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act. Several of the Microbiologics product lines are not intended as in-vitro, medical diagnostic products and may not be subject to the FDA QSR. However, regardless of intended applications or use, all of Microbiologics products are placed under, and meet, the provisions of FDA QSR. ISO 9001 Microbiologics is an ISO 9001 Certified Company and is subject to external audits on a regular schedule. Conformity to ISO 9001 ensures that the design, production and distribution of products are performed under, and conform to, the provision of a documented quality management system. ISO 17025 In February 2008, the Laboratory at Microbiologics achieved accreditation to the ISO 17025 standard within their scope of accreditation. The importance of gaining accreditation to this standard is that it provides additional recognition of the quality of the laboratory work that our products undergo during the Quality Assurance process. ISO Guide 34 In May 2009, Microbiologics received their accreditation to ISO Guide 34 “General requirements for the competence of reference material producers.” This accreditation ensures that a management system is maintained which provides technical support to the programs of the corporation by consistently producing quality Certified Reference Materials (CRM). Page 86 Microbiologics® Retail Products: 38th Edition LIT.014 REVISION 2010.March.15
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Convenience With Confidence Quality
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PHARMACEUTICAL, COSMETIC AND DIETAR
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LYFO DISK® Vial KWIK-STIK® 10Pk 2
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New Products for the 38th Edition 5
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New Products for the 38th Edition 5
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Product Overview Product Line Packa
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Customer Service Our friendly Custo
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Mean Assay Value The mean assay val
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Trademarks 1. Microbiologics® Trad
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LYFO DISK ® Instructions for Use K
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Individual Microorganisms LYFO DISK
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Notes Page 26 Microbiologics® Reta
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Choose from three convenient packag
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Microorganism Sets CAT# Commercial
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Microorganism Sets CAT# 5148† Com
Page 53 and 54: Microorganism Sets CAT# Commercial
Page 55 and 56: Microorganism Sets CAT# Commercial
Page 57 and 58: Microorganism Sets CAT# 5031† Mis
Page 59 and 60: KWIK-STIK Plus Instructions for Us
Page 61 and 62: KWIK-STIK Plus CAT# Product Descrip
Page 63 and 64: EZ-COMP TM Instructions for Use Als
Page 65 and 66: Notes Page 46 Microbiologics® Reta
Page 67 and 68: Visit www.microbiologics.com or cal
Page 71 and 72: EZ-FPC TM Instructions for Use 1 2
Page 75 and 76: EZ-SPORE TM Instructions for Use Vi
Page 79 and 80: EZ-Accu Shot kits include: • 5 vi
Page 83 and 84: EZ-CFU kits include: • 20 lyophil
Page 87 and 88: EZ-CFU One Step kits include: • 2
Page 91 and 92: EZ-PEC Kits include • 20 lyophili
Page 95 and 96: Instructions for Use When performin
Page 97 and 98: Epower CAT# PRODUCT DESCRIPTION BSL
Page 99 and 100: TECHNICAL INFORMATION BULLETIN TIB.
Page 101 and 102: TECHNICAL INFORMATION BULLETIN TIB.
Page 103: TECHNICAL INFORMATION BULLETIN TIB.
Page 107: GENERAL INFORMATION PRODUCT WARRANT
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2010 Catalogue.pdf - Abacus ALS

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