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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 32A Automated Viral DNA/RNA Isolation Kit; 96A Automated Viral DNA/RNA Isolation Kit; ANDiS Viral RNA Auto Extraction & Purification Kit; Automated Nucleic Acids Extraction System ANDiS 396; ReadiMag FFPE DNA/RNA Kit; ReadiMag Pathogen Nucleic Acid Isolation Kit; ReadiMag™ FFPE DNA Isolation Kit; ReadiMag™ gDNA Isolation Kit
Classification Name: CLINICAL SAMPLE CONCENTRATOR
Product Code: JJH
Device Class: 1
Regulation Number: 862.2310
Medical Specialty: Clinical Chemistry
Registered Establishment Name: 3D BIOMEDICINE SCIENCE & TECHNOLOGY CO., LIMITED
Registered Establishment Number: 3016764493
Owner/Operator: 3D Biomedicine Science & Technology Co., Limited
Owner/Operator Number: 10063312
Establishment Operations: Manufacturer
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