RADI PREP Plus - RADI PREP PLUS(Refer to Figure 1.) is an - KH Medical Co., Ltd.

Duns Number:695801965

Device Description: RADI PREP PLUS(Refer to Figure 1.) is an instrument capable of extracting nucleic acid nee RADI PREP PLUS(Refer to Figure 1.) is an instrument capable of extracting nucleic acid needed in various sample as blood, serum, sputum and tissues for the gene amplification test. RADI PREP PLUS instrument is designed for use by laboratory professionals. 8 samples can be prepared in a single run. This Instrument is controlled through a graphical user interface.RADI PREP PLUS 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 7 inches 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 PREP Plus

Version/Model Number

KM001

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

f24dddf6-d460-41d7-8d27-b277d4552452

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