RADI 192 Whole Blood DNA/RNA Extraction Kit

Basic Information

• Brand Name: RADI 192 Whole Blood DNA/RNA Extraction Kit
• Primary DI: 08800204300508
• Version / Model: OP003
• Company Name: KH Medical Co., Ltd.
• Labeler DUNS: 695801965
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-19
• Public Version: 2
• Public Version Date: 2022-11-18
• Public Version Status: Update
• Public Device Record Key: 8b4a778c-1f25-4e15-816e-e5f7995ffa88

Device Description

This product is based on magnetic extraction method that separates nucleic acids using a silica-coated magnetic bead. The sample is first lysed by the provided Lysis buffer to expose the nucleic acid, and the exposed nucleic acid is binds to the Silica-coated magnetic bead, and impurities are removed by the washing buffer. After this, the purified DNA/RNA is eluted with an Elution buffer.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
52521	Nucleic acid extraction/isolation kit IVD	A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800204300508	GS1