FDA.reportPublic FDA data

TARGETINGONE

Primary DI
06974689626018
Brand
TARGETINGONE
Company
TargetingOne Technology (Beijing) Corporation
Model
C10 easyPCR System/C10
Published
2023-10-20
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
06974689626018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974689626018069746896260186974689626018

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
541198269
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974689624212TARGETINGONEDigital PCR analysis System/D12023-10-20
06974689624229TARGETINGONEDigital PCR analysis System/D22023-10-20
06974689625080TARGETINGONEChip Reader/Chip Reader R22023-10-20
06974689625097TARGETINGONEDrop Maker/Drop Maker M12023-10-20
06974689625103TARGETINGONEChip Reader/ Chip Reader R12023-10-20
06974689625134TARGETINGONEC0 Thermal Cycler/ C02023-10-20
06974689625141TARGETINGONEE10 Nucleic Acid Extraction System/E102023-10-20
06974689625158TARGETINGONEC1 easyPCR Analyzer/C12023-10-20
06974689625165TARGETINGONEC6 easyPCR Analyzer/C62023-10-20
06974689625172TARGETINGONE D50 Automatic Digital PCR System/D502023-10-20
06974689625189TARGETINGONED30 Automatic Digital PCR System /D302023-10-20
06974689624014TARGETINGONENucleic acid extraction reagent (cfDNA)/ cfDNA-B12023-10-20
06974689624021TARGETINGONENucleic acid extraction reagent (cfDNA)/ cfDNA-B1c2023-10-20
06974689624038TARGETINGONENucleic acid extraction reagent (FFPE TNA)/FFPE TN2023-10-20
06974689624045TARGETINGONENucleic acid extraction reagent (FFPE TNA)/FFPE TN2023-10-20
06974689624052TARGETINGONENucleic acid extraction reagent (FFPE TNA)/FFPE TN2023-10-20
06974689624069TARGETINGONENucleic acid extraction reagent (FFPE TNA)/FFPE TN2023-10-20
06974689624076TARGETINGONENucleic acid extraction reagent (FFPE DNA)/FFPE DN2023-10-20
06974689624083TARGETINGONENucleic acid extraction reagent (FFPE DNA)/FFPE DN2023-10-20
06974689624090TARGETINGONENucleic acid extraction reagent (Cell DNA)/CELL DN2023-10-20

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