RADI 192 Viral DNA/RNA Extraction Kit

GUDID 08800204300034

This product is a nucleic acid extraction reagent capable of extracting high-purity DNA/RNA from plasma, saliva, feces, urine, amniotic fluid, and bone marrow of suspected virus infection patients using a Buffer Cartridge dispensed with reagents necessary for nucleic acid extraction.

KH Medical Co., Ltd.

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 08800204300034
• NIH Device Record Key: b73cacaa-66c1-44ac-a625-f6bc2438cc17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RADI 192 Viral DNA/RNA Extraction Kit
• Version Model Number: OP002
• Company DUNS: 695801965
• Company Name: KH Medical Co., Ltd.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800204300034 [Primary]

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: 2022-09-27
• Device Publish Date: 2022-09-19

On-Brand Devices [RADI 192 Viral DNA/RNA Extraction Kit]

• 08800204300508: This product is based on magnetic extraction method that separates nucleic acids using a silica-
• 08800204300034: This product is a nucleic acid extraction reagent capable of extracting high-purity DNA/RNA from