RADI Extractor 192

GUDID 08800204300027

RADI EXTRACTOR 192 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI EXTRACTOR 192 instrument is designed for use by laboratory professionals. RADI EXTRACTOR 192 has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System.

KH Medical Co., Ltd.

Nucleic acid sample preparation instrument IVD

• Primary Device ID: 08800204300027
• NIH Device Record Key: 25849841-2fe8-4ec3-9c9b-e67bc87d8a3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RADI Extractor 192
• Version Model Number: OE006
• Company DUNS: 695801965
• Company Name: KH Medical Co., Ltd.
• Device Count: 1
• DM Exempt: true
• 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: 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800204300027 [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: 2022-09-27
• Device Publish Date: 2022-09-19

Devices Manufactured by KH Medical Co., Ltd.

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• 08800204300010 - RADI PREP Plus: 2022-09-27 RADI PREP PLUS(Refer to Figure 1.) is an instrument capable of extracting nucleic acid needed in various sample as blood, serum,
• 08800204300027 - RADI Extractor 192: 2022-09-27RADI EXTRACTOR 192 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI EXTRACTOR 192 instrument is designed for use by laboratory professionals. RADI EXTRACTOR 192 has various functions such as liquid handling, bead mixing, sample lysis, nucleic acid separation, etc. Also, with its compact size and light weight, it offers high efficiency in terms of space and portability. It is convenient for users to easily use the instrument through a user interface in the LCD touch screen. The protocol which is used for by USB port, and all the functions including modification of Extraction protocol from the control software in the PC can be used. All the protocols the user edited are stored in System.
• 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
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• 08800204300096 - RADI CHAMP260: 2022-09-27 The RADI CHAMP260 is a stand-alone automated isothermal amplification and detection system for target nucleic acid sequences fo
• 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