FDA.reportPublic FDA data

TARGETINGONE

Primary DI
06974689624151
Brand
TARGETINGONE
Company
TargetingOne Technology (Beijing) Corporation
Model
Nucleic acid extraction reagent/ Pathogens TNA-P2
Device description
Model: Pathogens TNA-P2, Specification: 96 tests/box
Published
2023-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PEGNucleic Acid Quantitation Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEGNucleic Acid Quantitation KitClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974689624151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974689624151069746896241516974689624151

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
541198269
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
06974689626018TARGETINGONEC10 easyPCR System/C102023-10-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974689624014TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624021TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624038TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624045TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624052TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624069TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624076TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624083TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624090TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624113TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624120TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624137TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624144TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624168TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624175TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624182TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624199TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624236TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624243TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624250TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624267TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-10-20
06974689624007TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-09-14
00849811075902QuantiFluor® Dx dsDNA SystemPROMEGA CORPORATIONPEG2023-08-15
06974689624106TARGETINGONETargetingOne Technology (Beijing) CorporationPEG2023-02-15