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品質ドキュメント

Repligen facilities operate according to ISO 9001 Quality Management Systems (QMS), with the aim of building quality into every Repligen product.

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透析

SpectraFlo™動的透析システム

Float-A-Lyzer^® G2 Ready-to-use Microdialysis Devices

Micro Float-A-Lyzer^®即使用可能な微小透析デバイス

Tube-A-Lyzer^®動的透析システム

Spectra/Por^®バイオテックグレードの透析メンブレン：セルロースエステル（CE）、再生セルロース（RC）

Spectra/Por^®1～7 標準グレードの再生セルロース透析メンブレン

Spectra/Por^®In Vivo微小透析中空糸フィルター

Spectra/Gel^®アブゾーバント

KrosFlo^® KR1 Pump System, Stand Kit

ELISAキット

LONG^®R³ IGF-I ELISA Kit User Guide

ELISA nPA rPA User Guide

ELISA NGL Impact A User Guide

ELISA MabSelect User Guide

KrosFlo^®TFDF^® Systems

KrosFlo^® TFDF^® Lab System User Guide

KrosFlo^® TFDF^® Lab System Set-up Guide

KrosFlo^® TFFシステム

KrosFlo^® KR2i / KMPi TFF Systems with KONDUiT User Guide

KrosFlo^® KR1 Pump System, Stand Kit

KrosFlo^® Digital Pressure Monitor

Ultra Precision Scale

Saw Scale (with MKE-5)

KF Comm 2 Software User Guide

OPUS^® Pre-packed Chromatography Columns

OPUS^® 5-80R Pre-packed Chromatography Columns User Guide

Uncrating OPUS^® 45-60R Pre-packed Chromatography Columns

Uncrating OPUS^® 80R Pre-packed クロマトグラフィー Columns

Unpackaging OPUS^® 10-30 Pre-packed クロマトグラフィー Columns

OPUS^® 1.2 – 2.5 クロマトグラフィー Columns Pre-packed with CaptivA^® Resin User Guide

OPUS^® RoboColumn^®User Guide

OPUS^® ValiChrom™ User Guide

Protein A Affinity Resins

CaptivA^® Protein A Affinity Resin User Guide

OPUS^® 1.2 – 2.5 Chromatogaphy Columns Pre-packed with CaptivA^® Resin User Guide

Spectra/Chrom^® Chromatography Supplies

CF-2 Fraction Collector

Model 280 UV Monitor

Spectra/Chrom^® Chart Recorder

IS-95 Interval Sampler

S-3 Solvent Saver System

Spectrum^® Hollow Fiber Filters and Membranes

Spectrum^®MicroKros and MidiKros Hollow Fiber Modules

Spectrum^®Hollow Fiber Filter Module Preparation

TangenX™ TFF Flat Sheet Casssettes

TangenX^® PRO Cassette User Guide

TangenX^® SIUS™ PD Cassette User Guide

X-Flo76™ User Guide

Disc Membrane User Guide

TangenX™ PRO PD Cassette User Guide

TangenX™ SIUS™ Cassette

EH10236 TangenX™ Hydraulic Pump User Guide

TangenX™ PRO PD Low Holdup Volume (LHV) System User Guide

TangenX™ PRO PD Cassette Holder Compatibility Guide

TangenX™ SIUS™ PD Cassette Holder Compatibility Guide

TangenX™ PRO Cassette Holder Compatibility Guide

TangenX™ SIUS™ Cassette Holder Compatibility Guide

TangenX™ SIUS™ Filter Plate and 4-Bolt Clamp Assembly

TangenX™ SIUS™ PD Filter Plate and 2-Bolt Clamp Assembly User Guide

XCell ATF^® Devices

XCell ATF^® 2シングルユースデバイススタートアップガイド

XCell ATF^® 6シングルユースデバイススタートアップガイド

XCell ATF^® 10シングルユースデバイススタートアップガイド

XCell ATF^® System with C410:V4B Controller

XCell ATF^® System with C410:V3 Controller

XCell ATF^®システムフィルター調製およびオートクレーブ滅菌

レギュラトリーサポートファイル

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OPUS^® Pre-packed Chromatography Columns

OPUS^® Columns Regulatory Support File

Protein A Affinity Resins

CaptivA^® Protein A Affinity Resin Regulatory Support File

IPA 400HC Protein A Affinity Resin Regulatory Support File

Protein Aリガンド

Native Recombinant Staphylococcal Protein A Lignad (rSPA) Regulatory Support File

Spectrum^® Hollow Fiber Filters

Spectrum^®mPES Hollow FIber Filter Modules Regulatory Support File

安全データシート

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細胞培養サプリメント

LONG^®R³ IGF-I - Freeze-dried - Material Safety Data Sheet

LONG^®R³ IGF-I - 液体タイプ - 製品安全データシート

LONG^®EGF - フリーズドライ - 製品安全データシート

ELISAキット

Protein A ELISA Kit for Native and Recombinant Protein A (9000-1)

試薬A
試薬D

Protein A ELISA Kit for MabSelect SuRe Ligand (9333-1)

試薬A
試薬D

LONG^®R³ IGF-I ELISA Kit (9547-1)

試薬D

Protein A Affinity Resins

CaptivA^® Protein A Affinity Resin Material Safety Data Sheet

Immobilized rProtein A (IPA 300S) Material Safety Data Sheet

Immobilized rProtein A (IPA-400HC) Material Safety Data Sheet

Protein Aリガンド

Recombinant Protein A (srPA50, rSPA) Material Safety Data Sheet

Native Protein A Material Safety Data Sheet

TangenX™ Cassettes

TangenX™ PRO Cassette Safety Data Sheet

TangenX™ SIUS Cassette Safety Data Sheet

Certificates of analysis and quality - Examples

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細胞培養サプリメント

LONG^®R³ IGF-I Certificate of Analysis - Freeze-dried - Example

LONG^®R³ IGF-I Certificate of Analysis - Liquid - Example

LONG^® EGF Certificate of Analysis - Freeze-dried - Example

ELISAキット

LONG^®R³ IGF-I ELISA Kit Certificate of Analysis - Example

Protein A ELISA Kit for the Detection of MabSelect SuRe™ Ligand Certificate of Analysis - Example

Protein A ELISA Kit for Native and rProtein A Certificate of Analysis - Example

OPUS^® Pre-packed Chromatography Columns

OPUS^® Pre-packed Chromatography Column Certificate of Analysis Pre-GMP - Example

OPUS^® Pre-packed Chromatography Column Certificate of Analysis GMP Run Ready - Example

Protein Aリガンド

APB Recombinant Protein A (rPA-APB) Certificate of Analysis - Example

Recombinant Staphylococcal Protein A (rSPA) Certificate of Analysis - Example

Soy Fermented Recombinant Protein A (srPA-50) Certificate of Analysis - Example

Native Protein A Certificate of Analysis - Example

XCell ATF^® System

XCell ATF^® System Certificate of Quality - Example

品質システム管理ドキュメント

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米国

ISO9001:2015 Certificate of Registration - US (Waltham)

ISO9001:2015 Certificate of Registration - US (Rancho Dominguez)

ISO 13485:2016 Certificate of Certification - US (Irving)

EN ISO 13485:2016 Certificate of Certification - US (Irving)

Quality Policy - US

Sweden

ISO 14001:2015 Certificate - Sweden

ISO 9001:2015 Certificate - Sweden

Environmental Policy - Sweden

Quality Policy - Sweden

Quality and Animal-free Statements

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細胞培養サプリメント

LONG^®R³ IGF-I 品質記述

LONG^®R³ IGF-I 動物質不使用に関する声明

LONG^®EGF 品質記述

LONG^®EGF 動物質不使用に関する声明

OPUS^® Pre-packed Chromatoraphy Columns

General Quality Statement

BSE and TSE Free Statement

Melamine and BPA Free Statement