AccessGUDID - DEVICE: RADI PREP Plus (08800204300010)

GUDID

Device Identifier (DI) Information

Brand Name: RADI PREP Plus
Version or Model: KM001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KH Medical Co., Ltd.

Primary DI Number: 08800204300010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695801965 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60736	Nucleic acid sample preparation instrument IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	Clinical Sample Concentrator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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