RADI 192 Bacteria DNA/RNA Extraction Kit

GUDID 08800204300522

The RADI 192 Bacteria DNA/RNA Extraction kit is a reagent intended to extract Bacterial DNA and RNA from urine, stool, swab and pre-treated sputum (NaOH, NALC). Automated nucleic acid extraction can be performed with this kit by using RADI 192 Extractor only. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS. The kit is intended to be use by a laboratory professional.

KH Medical Co., Ltd.

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 08800204300522
• NIH Device Record Key: 8b6d5156-dc6e-4251-94d3-6bb816612072
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RADI 192 Bacteria DNA/RNA Extraction Kit
• Version Model Number: OP005
• 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	08800204300522 [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

Devices Manufactured by KH Medical Co., Ltd.

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• 08800204300027 - RADI Extractor 192: 2022-09-27 RADI EXTRACTOR 192 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tiss
• 08800204300034 - RADI 192 Viral DNA/RNA Extraction Kit: 2022-09-27 This product is a nucleic acid extraction reagent capable of extracting high-purity DNA/RNA from plasma, saliva, feces, urine, a
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• 08800204300102 - RADI PREP Plus 48: 2022-09-27 The RADI PREP PLUS 48 is designed as a fully automated instrument for nucleic acid extraction and purification from various biol
• 08800204300133 - RADI Extractor 32: 2022-09-27 RADI EXTRACTOR 32 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissu