FDA.reportPublic FDA data

RADI PCR 96 Plus

Primary DI
08800204300690
Brand
RADI PCR 96 Plus
Company
KH Medical Co., Ltd.
Model
KM005
Published
2022-10-11
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
08800204300690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800204300690088002043006908800204300690

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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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