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21 CFR Part 11 Compliance for the LS 13 320 XR Particle Size Analyzer

$LS 13 320 XR Laser Diffraction Particle Size Analyzer with PIDS technology$

How the LS 13 320 XR particle size analyzer help you comply with 21 CFR part 11

QC Step: Raw Material
Application: Active Pharmaceutical Ingredient, Excipients
Regulation: ISO 13320

Attributable: Multi-level, individual user name and password for all users
Legible: Legible, secure PDF export as well as audit trail and measurement results
Contemporaneous: Secure PDF created on day of sample analysis
Original: Original electronic record created directly from the instrument
Accurate: SOP parameters pre-programed into the instrument and automated

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NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES. PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS The listed regulatory status for products correspond to one of the below: IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use." ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagent. Analytical and performance characteristics are not established." CE-IVD, CE: Products intended for in vitro diagnostic use and conforming to the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. (Note: Devices may be CE marked to other directives.) RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures." LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only." No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.