RADI PREP Plus

Primary DI
08800204300010
Brand
RADI PREP Plus
Company
KH Medical Co., Ltd.
Model
KM001
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.
Published
2022-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJHClinical Sample Concentrator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800204300010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800204300010088002043000108800204300010

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sample preparation instrument IVDAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695801965
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800204300690RADI PCR 96 PlusKM0052022-10-11
08800204300096RADI CHAMP260KM0022022-09-19
08800204300720RADI PREP PLUS 48 Universal DNA/RNA KitAP1102023-01-03
08800204300706RADI 32 Viral DNA/RNA Extraction KITOP0012022-11-17
08800204300508RADI 192 Whole Blood DNA/RNA Extraction KitOP0032022-09-19
08800204300027RADI Extractor 192OE0062022-09-19
08800204300034RADI 192 Viral DNA/RNA Extraction KitOP0022022-09-19
08800204300102RADI PREP Plus 48KM0032022-09-19
08800204300133RADI Extractor 32OE0052022-09-19
08800204300300RADI PREP PLUS Swab and Stool DNARNA KITAP0062022-09-19
08800204300515RADI 192 Tissue DNA/RNA Extraction KitOP0042022-09-19
08800204300522RADI 192 Bacteria DNA/RNA Extraction KitOP0052022-09-19
08800204300539RADI 48 Viral DNA/RNA Extraction kitAP1022022-09-19
08800204300546RADI PREP PLUS 48 Swab DNA,RNA Extraction KitAP1012022-09-19
08800204300553RADI 48 Whole Blood DNA/RNA Extraction KitAP1032022-09-19
08800204300560RADI 48 Tissue DNA Extraction KitAP1042022-09-19
08800204300577RADI 48 Bacteria DNA Extraction KitAP1052022-09-19
08800204300683RADI PREP PLUS Universal DNA/RNA KITAP0102022-09-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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