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Chemical / Physical Characterization – Information

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Genotoxicity – Mouse Lymphoma Assay.

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Carcinogenicity Study

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Genotoxicity – Bacterial Reverse Mutation Study.

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Subacute – Subchronic Systemic Toxicity Study Following Implant

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Subacute – Subchronic Systemic Toxicity Study Following Implant.

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ISO Muscle Implantation Study.

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ISO Pyrogen Study – Material Mediated

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Genotoxicity – Chromosomal Aberation / Mammalian Cells – Japanese MHLW

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Genotoxicity – Bacterial Reverse Mutation Study – Japanese MHLW

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Cytotoxicity Study – Colony Assay – Japanese MHLW

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ISO-10993-18 Chemical Characterization

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Biological Risk Assessment / Safety Evaluation Plan

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ISO Pyrogen Study – Material Mediated.

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Gram Stain and Colony Morphology

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USP/NF Monograph Testing – Potentiometric Titration

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ADA Oral Toxicity Study

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CFR General Safety Study

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Oral Mucosal Irritation Study – Surgical Method

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Intravitreal Injection Study

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JP Systemic Toxicity Study

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USP Muscle Implantation Study

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Bioburden Recovery Validation – Repetitive

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Zone of Inhibition

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Environmental Monitoring of Viable Organisms

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Filter Effectiveness Study (HIMA)

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AATCC Test Method 30, Part III

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Bioburden Recovery Validation – Inoculative

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AATCC Test Method 100

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Identification of Fungi Using an Automated Biochemical System

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Kirby-Bauer Susceptibility Test

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Sterility Dose Set

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Preservative Effectiveness Test USP

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Microbiological Examination of Nonsterile Products; USP 61 Microbial Enumeration Test, and USP 62 Test For Specified Microorganisms

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Sterilization – EO Conventional Chamber

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Bacteriostasis / Fungistasis

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Alkaline Phosphatase Activity

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Sterility-Inoculated Product

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AATCC Test Method 147

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AATCC Test Method 174 Part I

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AATCC Test Method 174, Part II

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USP Growth Promotion

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USP (LAL) Test – Kinetic Turbidimetric Method (Pos, Neg, Inhib)

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USP (LAL) Testing – Gel – Clot Method

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USP (LAL) Limulus Amebocyte Lysate Testing, Kinetic-Chromogenic

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In Vivo Osteoinduction Assay

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Bone Morphogenic Protein 2 (BMP-2) – In Vitro Osteoinduction Test

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Sterility-in situ-Product

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Sterility Positive Investigation Report

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Sterility-Direct Transfer Method

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AATCC Test Method 174, Part III

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Antimicrobial Evaluation Pink Stain Test

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USP <1227>

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USP <55> Total Viable Spore Count

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ASTM E2149

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DNA Microbial ID with MicroSEQ

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Sterility – Membrane Filtration

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ICH Stability Aging Chambers

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Ultra Performance Liquid Chromatography/Mass Spectrometry (UPLC/MS)

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Determination of Extractable Volatile Organic Compounds by Headspace GC/MS

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Residual Acetate Determination by Ion Chromatography

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Inductively Coupled Plasma Mass Spectroscopy (ICP-MS), Full Scan

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Rotational Viscosity Determination

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USP Cysteine Hydrochloride – Assay and Loss on Drying

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Specific Gravity of Liquids

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Blank Glassware Analysis – Analysis of Semi-Volatile Organic Residuals Gas Chromatography

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USP <661>, Containers – Plastics, Polypropylene Container, Complete

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USP <671>, Containers, Light Transmission

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Visual Inspection of Medical Packaging to Determine Integrity

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External Standards Testing

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Preliminary Extraction Test – Japanese MHLW

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Exaggerated Extraction Procedure – Japanese MHLW

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Determination of Extractable Semi – Volatile Organic Compounds by GC/MS

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Exhaustive Extraction

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ISO Ophthalmic Implants – Intraocular Lenses: Test for Hydrolytic Stability

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Chemical Residue by Gravimetric Analysis

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Package Seal Dye Penetration for Glass Vials

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Determination of Extractable Elements by Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP-OES) Full Scan

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USP/NF Monograph Testing – Potentiometric Titration

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Inoculation

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Total Viable Spore Count

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EO Survival/Kill Time Verification

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Dry Heat Survival/Kill Time Verification

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Steam Sterilization

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Spore Stain

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Bioburden

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Cycles performed in the automated washer/disinfector

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Extraction of Medical Devices for Cleaning Studies

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Protein Analysis, in Support of Cleaning Studies

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Hemoglobin Analysis, in support of cleaning studies

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Carbohydrate Analysis, in support of cleaning studies

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21CFR177.1520 polypropylene or polymethylpentene

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21CFR177.1520 polyethylene

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Transportation Simulation Testing

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Soiling and Manual Cleaning of Medical Devices

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Soiling and Automated Cleaning of Medical Devices

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Identification of Microorganisms – Aerobic Bacteria/Yeast

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Gurley Method Air Permeance Determination

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Automated Washer/ Disinfector Cycle for validation of processing/ reprocess of medical devices

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Anion and Cation analysis by Ion Chromatography

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Digestion of Samples for ICP

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EP 3.2.9 and USP Monograph Testing

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USP Glass Container Testing, Complete

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USP Polyethylene Container Testing, Complete

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USP Polyethylene Terephthalate Bottle Testing

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JP Test for Rubber Closure for Aqueous Infusions

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Demineralized Bone PrepaSubjection

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Osteoinduction Activity – C2C12 Cell Culturing

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Protein Concentration Determ. – Bicinchoninic Acid (BCA) Kit

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Alkaline Phosphatase Activity Determ. – ALP Assay Kit

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Chronic Systemic Toxicity Study in Subjects Following Implant

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Systemic Toxicity Study – Repeated Parenteral Subjection

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Absorption Capacity Testing for Chemistry

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pH Determination

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USP Physicochemical Tests for Plastics (Aqueous), Complete

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Physicochemical Tests for Elastomeric Closures, Complete

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ISO Vaginal Irritation Study

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USP Systemic Toxicity Study – Extract

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FHSA Dermal Toxicity Study

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USP Safety Study

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Maximization Sensitization Study – Japanese MHLW

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ISO Closed Patch Sensitization Study

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ISO Maximization Sensitization Study

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USP Acute Toxicity Study

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Systemic Toxicity Study – Japanese MHLW

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ISO Acute Systemic Toxicity Study – Extract

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Systemic Toxicity Study – Solution

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FHSA Oral Toxicity Study

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Oral Toxicity Study

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Ethylene Glycol Analysis

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Infrared Analysis

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JP Test Methods for Plastic Containers

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JP Monograph Testing

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Osmolarity/Osmolality Determination

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Burst and Creep Package Evaluation Tests

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Instron Testing of Materials

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EP Monograph Testing

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ASTM Condom Testing

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Total Extractables in Repeated Use Rubber Articles

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USP/NF Monograph Testing

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USP Purified Water Testing – Total Organic Carbon

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Package Seal Dye Penetration

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Vacuum Leak Test

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USP Sterile Purified Water – Chemical Analysis

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Particulate Analysis

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Gas Chromatography

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High Performance Liquid Chromatography (HPLC)

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ASTM D2240 Durometer Hardness

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Ultraviolet/Visible Scan

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Ethylene Oxide Analysis

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Melting Point Determination

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Aging/Thermal Conditioning – Program Schedule

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Karl Fischer Method for Determination of Water Content

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Specific Gravity

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Refractive Index Determination

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SC5b-9 Complement Activation Assay

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Genotoxicity – Chromosomal Aberation / Mammalian Cells

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Genotoxicity – Bacterial Reverse Mutation Study

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Genotoxicity – Mouse Lymphoma Assay

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Thrombo-resistance Study

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C3a Complement Activation Assay

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ASTM Hemolysis

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ASTM Partial Thromboplastin Time

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Genotoxicity, Mouse Peripheral Blood Micronucleus Study

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Cytotoxicity Study – ISO Direct Contact Method

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EP Pyrogen Study

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Intraocular Irritation Study

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Cytotoxicity Study Using the MEM Elution Method

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Cytotoxicity Study Using the Agarose Overlay Method

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Cytotoxicity Study Using the USP Agar Diffusion Method

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Cytotoxicity Study Using the USP Elution Method

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Cytotoxicity Study Using the ISO Elution Method

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Cytotoxicity Study Using the ISO Agarose Overlay Method

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Histopathology – Multiple Services Offered

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USP Iron Dextran Absorption Study

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ISO Ocular Irritation Study

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ISO Contact Lens/Solution Ocular Irritation Study

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ISO Penile Irritation Study

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ISO Skin Irritation Study

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USP Intracutaneous Study

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In Vitro Irritation Assay

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MHLW Pyrogen Study, Material Mediated

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USP Pyrogen Study

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ISO Intracutaneous Study

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Oral Mucosal Irritation Study – Collar Method

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Muscle Implantation Study, Japanese MHLW

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ISO Subcutaneous Implantation Study

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ISO Muscle Implantation Study

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JP Pyrogen Study

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Intracutaneous Study – Japanese MHLW

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FHSA Skin Irritation Study

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FHSA Ocular Irritation Study

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Urinary Bladder Irritation Study

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MTT Cytotoxicity Study

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