RADI 32 Viral DNA/RNA Extraction KIT

GUDID 08800204300706

The RADI 32 Viral DNA/RNA Extraction kit is a reagent used to extract nucleic acids from bacteria and viruses present in samples collected from vagina, or pharynx using cotton swabs. Automated nucleic acid extraction can be performed by RADI 32 Extractor. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS. The kit is for use by a laboratory professional.

KH Medical Co., Ltd.

Nucleic acid extraction/isolation kit IVD
Primary Device ID08800204300706
NIH Device Record Key66389081-8dc0-45cf-bdb5-1a0867e408bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRADI 32 Viral DNA/RNA Extraction KIT
Version Model NumberOP001
Company DUNS695801965
Company NameKH Medical Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800204300706 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-25
Device Publish Date2022-11-17

Devices Manufactured by KH Medical Co., Ltd.

08800204300706 - RADI 32 Viral DNA/RNA Extraction KIT2022-11-25The RADI 32 Viral DNA/RNA Extraction kit is a reagent used to extract nucleic acids from bacteria and viruses present in samples collected from vagina, or pharynx using cotton swabs. Automated nucleic acid extraction can be performed by RADI 32 Extractor. The extracted nucleic acid can be used in all experiments that require nucleic acids, such as real-time PCR and NGS. The kit is for use by a laboratory professional.
08800204300706 - RADI 32 Viral DNA/RNA Extraction KIT2022-11-25 The RADI 32 Viral DNA/RNA Extraction kit is a reagent used to extract nucleic acids from bacteria and viruses present in samples
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08800204300027 - RADI Extractor 1922022-09-27 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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08800204300102 - RADI PREP Plus 482022-09-27 The RADI PREP PLUS 48 is designed as a fully automated instrument for nucleic acid extraction and purification from various biol
08800204300133 - RADI Extractor 322022-09-27 RADI EXTRACTOR 32 is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissu

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