RADI CHAMP260

Primary DI
08800204300096
Brand
RADI CHAMP260
Company
KH Medical Co., Ltd.
Model
KM002
Device description
The RADI CHAMP260 is a stand-alone automated isothermal amplification and detection system for target nucleic acid sequences found in human specimens. The instrument is used in conjunction with KH Medical’s LOOP-Mediated Amplification in vitro diagnostic products.RADI CHAMP260 is designed to freely manipulate specific temperature and running time for amplification of samples by 7 inch touch screen.Amplification of target DNA occurs during the heat cycle and results in the formation of precipitate detected by the RADI CHAMP260 optics system. The precipitate generated by the presence of amplified target DNA leads to a turbid Sample/Control reaction solution which is then measured by absorbance. The RADI CHAMP260 uses the change in turbidity of each Sample/Control reaction solution to report assay results as INVALID, POSITIVE, or NEGATIVE on the 7 inch touch screen.
Published
2022-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800204300096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800204300096088002043000968800204300096

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.

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
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
08800204300010RADI PREP PlusKM0012022-09-19
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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