RADI Extractor 192 - RADI EXTRACTOR 192 is an instrument capable of - KH Medical Co., Ltd.

Duns Number:695801965

Device Description: RADI EXTRACTOR 192 is an instrument capable of extracting nucleic acid needed in various s 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.

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More Product Details

Catalog Number

-

Brand Name

RADI Extractor 192

Version/Model Number

OE006

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JJH

Product Code Name

Clinical Sample Concentrator

Device Record Status

Public Device Record Key

25849841-2fe8-4ec3-9c9b-e67bc87d8a3c

Public Version Date

September 27, 2022

Public Version Number

1

DI Record Publish Date

September 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KH MEDICAL CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 2