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  • GMP Consultants Pharmaceutical Architects and Validation

    As leading GMP consultants we offer a broad range of services from GMP compliance qualification validation TGA regulatory engineering and architectural consulting services to the following industries medicinal cannabis pharmaceutical blood tissue pesticides veterinary and medical device manufacturers as well as related hospital and pharmacy operations.

  • DxTerity Offers COVID-19 Tests For Sale on Amazon

    DxTerity is an ISO 13485-certified genomics company with a CLIA-licensed CAP-accredited laboratory based near Los Angeles CA. DxTerity develops highly accurate fast and affordable genomic tests for disease diagnosis and monitoring.

  • Quality System Regulation Labeling Requirements FDA

    2021-7-28 · Access to labeling should be limited to authorized personnel. Storage control should be appropriate for the number and kind of devices. For example a

  • ServicesSigma-Aldrich

    Services. We provide a wide variety of services related to many products processes and industries. Please select one of the categories below to learn more. Characterization. Contract Manufacturing. Custom Products. Product Services. Software Digital Platforms. Support.

  • Lymphoclonal™Cytognos S.L.

    Lymphoclonal™ is a 4-color antibody mixture aimed to study lymphocyte subsets and determine clonality of B-cells in peripheral blood bone marrow and other body fluids. Lymphoclonal™ is a rapid effective and reliable combination for initial screening of lymphocyte subsets which permits the identification of total T-cells (CD3 ) B-cells (CD19 ) and NK-cells (CD3- CD56 ) as well as helper

  • Durable Trendy medical using vial for Liquid Packaging

    About product and suppliers Explore the vast ranges of durable and trendy medical using vial at Alibaba for all types of liquid product packaging purposes. These medical using vial are made of high-quality materials that aid in lasting for a long time and also give them an enticing and appealing aesthetic appearance. The products are tested verified and certified for ensuring the

  • Aseptic Processing Fill-Finish Equipment by SP i

    The SY BI LI series is a line of filling equipment for injectables oral ophthalmics syringes and cartridges. Vial filling up to 200 vials per minute. The Aseptic filling series is made up of multiple models to cover a wide range of applications for the pharmaceutical industry.

  • Andersen ScientificContract Sterilization

    2020-12-18 · Andersen Scientific is so much more than a commercial sterilization facility. We prefer to consider ourselves as the research and development arm of your company. We work closely with your regulatory personnel to develop strategies in bringing your device to market and if you don t have a regulatory person we can put you in contact with

  • ACUSERA

    2020-7-31 · ISO 13485 2003 approval. ISO 13485 2003 relates to the design/development manufacture service and distribution of in vitro diagnostic medical devices in vitro diagnostic test kits in vitro diagnostic reagents and in vitro diagnostic analysers. ISO 13485 2003 highlights the requirements for a quality management system where an organisation needs

  • Foxx PS Sterile 1000ml Media Bottle (2/pack)MedLabGear

    Our patented SECURE grasp bottle cap enables easy handling and carrying of the bottle. The innovative cap also allows for easy uncapping tightening and bottle stacking and provides a large surface for bottle labeling. Foxx Life Sciences Autofil is manufactured in ISO 13485 clean room in

  • Tecan 1000uL Robotic Tips Liquid Sensing Hanging Format

    Extremely low-retention. Provides non-contaminated sample recovery. Eliminates sample carryover and delivers substantially higher reproducibility. Comes in racks for easy access and stackability each rack individually wrapped. Produced in ISO 9001 and ISO 13485 certified facilities. Quantity of 1536 tips per pack (16 racks of 96 tips)

  • Small Centrifuge at Thomas Scientific

    Z100A Clinical Lab Centrifuge. Labnet. The economical Z100A a small lab centrifuge features a 6 x 15 mL fixed angle rotor. The variable speed unit runs to 4 000 rpm/1 900 x g suitable for a variety of applications in the clinical setting or research lab. The rotor accepts six 15mL or 10mL tubes directly.

  • Tecan 50uL Robotic Tips Liquid Sensing Hanging Format

    Extremely low-retention. Provides non-contaminated sample recovery. Eliminates sample carryover and delivers substantially higher reproducibility. Comes in racks for easy access and stackability each rack individually wrapped. Produced in ISO 9001 and ISO 13485 certified facilities. Quantity of 2304 tips per pack (24 racks of 96 tips)

  • Tecan 1000uL Robotic Tips Liquid Sensing Hanging Format

    Extremely low-retention. Provides non-contaminated sample recovery. Eliminates sample carryover and delivers substantially higher reproducibility. Comes in racks for easy access and stackability each rack individually wrapped. Produced in ISO 9001 and ISO 13485 certified facilities. Quantity of 1536 tips per pack (16 racks of 96 tips)

  • Sterilization Pouches 7.5x13 Inches Pk 200MedLabGear

    Description. Autoclave Sterilization Pouches 8.5x13 inches pack of 200. Sterilization pouches are made of surgical grade paper and blue polypropylene/polyester film. Easy-to-open lip closure prefold self-adhesive strip and flat seals ensure seal integrity. Color-coded indicators on

  • Hardy Diagnostics Microbiology Culture Media and

    2021-8-14 · At Hardy Diagnostics you will find a complete selection of laboratory and microbiology supplies for the clinical industrial and molecular biology labs.

  • GMP Consultants Pharmaceutical Architects and Validation

    As leading GMP consultants we offer a broad range of services from GMP compliance qualification validation TGA regulatory engineering and architectural consulting services to the following industries medicinal cannabis pharmaceutical blood tissue pesticides veterinary and medical device manufacturers as well as related hospital and pharmacy operations.

  • Type-A Shielded Transport ContainersComecer

    2021-8-6 · Type-A Shielded Containers. Comecer Type-A Shielded Containers for transport are designed to survive transportation handling and are ideal for the

  • iPSC-derived CD34 Cells BXS0117 ATCC

    Human iPSC-derived CD34 can be used for drug development toxicity screening and cancer immunology experiments. There is reduced lot-to-lot variability in this cell line as they are all derived from the parental iPSC line (ATCC ACS-1031) .

  • Contact UsBD

    BD Corporate contact information BD Headquarters. Address Becton Dickinson and Company 1 Becton Drive Franklin Lakes NJ 07417-1880. Corporate phone number 201.847.6800 Investor information

  • Foxx PS Sterile 1000ml Media Bottle (2/pack)MedLabGear

    Our patented SECURE grasp bottle cap enables easy handling and carrying of the bottle. The innovative cap also allows for easy uncapping tightening and bottle stacking and provides a large surface for bottle labeling. Foxx Life Sciences Autofil is manufactured in ISO 13485 clean room in

  • Compliance Certification VWR

    ISO 13485. The ISO 13485 standard specifies the requirements for a comprehensive quality management system for the entire life-cycle a.o. production sales and supply of medical devices and in vitro diagnostics. ISO 17025

  • Recombinant Human IFN-gamma GMP Protein CF Bio-Techne

    Recombinant Human IFN-gamma GMP Protein Bioactivity GMP-grade Recombinant Human IFN-gamma (Catalog # 285-GMP) demonstrates anti-viral activity in HeLa human cervical epithelial carcinoma cells infected with encephalomyocarditis (EMC) virus. The ED 50 for this effect is 0.15-0.75 ng/mL.

  • Andersen ScientificContract Sterilization

    2020-12-18 · Andersen Scientific is so much more than a commercial sterilization facility. We prefer to consider ourselves as the research and development arm of your company. We work closely with your regulatory personnel to develop strategies in bringing your device to market and if you don t have a regulatory person we can put you in contact with

  • HSA Register Class B medical device via full route

    ISO 13485. Conformity to US FDA Quality System Regulations. Japan MHLW Ordinance 169. Manufacturing process flowchart. Further clinical data may be requested to support additional labelled uses of the device beyond its normal use. Additional documents. In addition to the CSDT documents you will also be required to submit the following

  • ACUSERA

    2020-7-31 · ISO 13485 2003 approval. ISO 13485 2003 relates to the design/development manufacture service and distribution of in vitro diagnostic medical devices in vitro diagnostic test kits in vitro diagnostic reagents and in vitro diagnostic analysers. ISO 13485 2003 highlights the requirements for a quality management system where an organisation needs

  • Contract Manufacturing Arrangements for Drugs Quality

    2018-10-8 · expanded access) or manufacturing of material for veterinary investigational drugs. Although this guidance does not explicitly apply to the manufacture of investigational

  • Aseptic Processing Fill-Finish Equipment by SP i

    The SY BI LI series is a line of filling equipment for injectables oral ophthalmics syringes and cartridges. Vial filling up to 200 vials per minute. The Aseptic filling series is made up of multiple models to cover a wide range of applications for the pharmaceutical industry.

  • Lymphogram™Cytognos S.L.

    Lymphogram™ is a 3-color mixture of monoclonal antibodies with carefully selected fluorescence intensities designed to simultaneously determine in peripheral blood bone marrow and other body fluids the major lymphocyte subpopulations including total T-cells (CD3 ) B-cells (CD19 ) and NK-cells (CD3- CD56 ) as well as helper (CD3 CD4 ) and cytotoxic (CD3 CD8 ) T-cell subsets.

  • Contact UsBD

    BD Corporate contact information BD Headquarters. Address Becton Dickinson and Company 1 Becton Drive Franklin Lakes NJ 07417-1880. Corporate phone number 201.847.6800 Investor information

  • ARGOS TECHNOLOGIES Polyethylene (PE) Cryogenic Vial PK

    Each vial features linear printed barcodes and a white surface area for specimen identification. Vials are manufactured in a class 7 clean room (class 10 000) in accordance with FDA GMP and ISO quality standards (ISO 13485 2004 ISO 14644 14698) and are certified to be DNase RNase pyrogen ATP and human DNA free. Sterilized by gamma

  • HelixMark® Silicone TubingMedLabGear

    HelixMark® Silicone TubingHelixMark® biomedical/pharmaceutical grade platinum-cured silicone tubing. Constructed using Dow Corning® SILASTIC® Q7-4750 material is ideal for use in transfer operations. Tubing meets USP Class VI and European Pharmacopoeia 3.1.9 biocompatibility requirements and is manufactured in Helix Medical s FDA registered medical device facility.

  • Pharmaceutical Manufacturing Resource

    PHARMACEUTICAL ONLINE CONTENT COLLECTIONS. In this roundtable Q A industry experts from AstraZeneca Takeda Biogen and NSF Health Sciences share insights on important topics related to human performance in pharmaceutical operations — offering insight into how forward-thinking organizations treat "human error" in the workplace.

  • Type-A Shielded Transport ContainersComecer

    2021-8-6 · Type-A Shielded Containers. Comecer Type-A Shielded Containers for transport are designed to survive transportation handling and are ideal for the

  • HelixMark® Silicone TubingMedLabGear

    HelixMark® Silicone TubingHelixMark® biomedical/pharmaceutical grade platinum-cured silicone tubing. Constructed using Dow Corning® SILASTIC® Q7-4750 material is ideal for use in transfer operations. Tubing meets USP Class VI and European Pharmacopoeia 3.1.9 biocompatibility requirements and is manufactured in Helix Medical s FDA registered medical device facility.

  • Corporate PresentationMicrobix

    2021-5-29 · • Licensed/ registered for sale in Canada EU and U.S. (vial and/or swab formats) • Sold directly to clinical lab chains or via distributors (5 Cos. 22 countries) • Growing sales of leading COVID-19 (SARS-Cov-2) and HPV controls • Targeting multiple lab and distributor accounts of > 100K/year

  • Quality System Regulation Labeling Requirements FDA

    2021-7-28 · Access to labeling should be limited to authorized personnel. Storage control should be appropriate for the number and kind of devices. For example a

  • CERTIFICATE OF COMPLIANCEWa

    2019-7-1 · Broken Bow facility is also ISO 13485 2003 certified. Broken Bow Quality Assurance Release date 2018/08/22 Name Erlinda Larsen This certificate is produced and controlled electronically and is valid without handwritten signatures. Page 1 of 1 BD Diagnostics Preanalytical Systems 150 South 1st Avenue Broken Bow NE 68822-2203 US

  • Impact of the EU MDR on Combination Product Sale and

    2021-2-11 · Consideration of certification to ISO 13485 by a pharmaceutical company the AstraZeneca director said should be driven by its product portfolio and global market access. He maintained however there is "definitely potential to leverage the pharmaceutical quality system to meet the EU MDR requirements for the quality system in Article 10."

  • Pharmaceutical Manufacturing Resource

    PHARMACEUTICAL ONLINE CONTENT COLLECTIONS. In this roundtable Q A industry experts from AstraZeneca Takeda Biogen and NSF Health Sciences share insights on important topics related to human performance in pharmaceutical operations — offering insight into how forward-thinking organizations treat "human error" in the workplace.

  • HepaSphere™ Microspheres (Outside US Only)Merit Medical

    Predictable. Retains spherical shape with consistent cross sectional diameter after reconstitution with aqueous-based solutions such as contrast media and 0.9 saline solution for predictable flow-directed level of occlusion in the vasculature.. Conformable. Affords atraumatic conformability to the architecture of the vessel lumen providing more contact surface area with the embolic