Protonion™ 96 Viral RNA Kit K-4731

GUDID 08809537070461

384 test/kit

Bioneer Corporation

Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 08809537070461
• NIH Device Record Key: dc37b32c-6c41-4b11-b4f1-522a0b47cef8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protonion™ 96 Viral RNA Kit
• Version Model Number: K-4731
• Catalog Number: K-4731
• 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	08809537070461 [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

Devices Manufactured by Bioneer Corporation

• 08809357174134 - ExiPrep™ Dx Viral RNA Kit: 2022-09-12 96 test/kit
• 08809357174158 - ExiPrep™ Dx Viral DNA/RNA Kit: 2022-09-12 96 test/kit
• 08809357174172 - ExiPrep™ Dx Viral DNA Kit: 2022-09-12 96 test/kit
• 08809357174196 - ExiPrep™ Dx Blood Genomic DNA Kit: 2022-09-12 96 test/kit
• 08809357174219 - ExiPrep™ Dx Bacteria Genomic DNA Kit: 2022-09-12 96 test/kit
• 08809357174233 - ExiPrep™ Dx Mycobacteria Genomic DNA Kit: 2022-09-12 96 test/kit
• 08809357178309 - ExiPrep™ 48 Viral DNA/RNA Kit: 2022-09-12 96 test/kit
• 08809357178316 - ExiPrep™ 48 Viral RNA Kit: 2022-09-12 96 test/kit