ExiPrep™ Dx Bacteria Genomic DNA Kit K-4414

GUDID 08809357174219

96 test/kit

Bioneer Corporation

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 08809357174219
• NIH Device Record Key: 0d4164ea-28f6-4c48-abd0-0c056a1b2672
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExiPrep™ Dx Bacteria Genomic DNA Kit
• Version Model Number: K-4414
• Catalog Number: K-4414
• Company DUNS: 688014216
• Company Name: Bioneer Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809357174219 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-12
• Device Publish Date: 2022-09-02

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