RADI PCR 96 Plus

GUDID 08800204300690

KH Medical Co., Ltd.

Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 08800204300690
• NIH Device Record Key: d31a888a-e5b0-44d6-9b68-d46e05d37888
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RADI PCR 96 Plus
• Version Model Number: KM005
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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	08800204300690 [Primary]

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification System

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: 2022-10-19
• Device Publish Date: 2022-10-11

Devices Manufactured by KH Medical Co., Ltd.

• 08800204300706 - RADI 32 Viral DNA/RNA Extraction KIT: 2022-11-25 The RADI 32 Viral DNA/RNA Extraction kit is a reagent used to extract nucleic acids from bacteria and viruses present in samples
• 08800204300690 - RADI PCR 96 Plus: 2022-10-19
• 08800204300690 - RADI PCR 96 Plus: 2022-10-19
• 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: 2022-09-27 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
• 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