FDA.reportPublic FDA data

TARGETINGONE

Primary DI
06974689624205
Brand
TARGETINGONE
Company
TargetingOne Technology (Beijing) Corporation
Model
Saliva collection kit/T1
Device description
"""Model: T1 Specification: 1 preps/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
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974689624205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974689624205069746896242056974689624205

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
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20885380169004CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
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04066916055998Screw cap, pastel-orangeSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056049Screw cap, pastel-violetSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056148Screw cap, pastel-yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056407Screw cap, pastel-blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057831SafeSeal tube 0.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057879SafeSeal tube 0.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058012SafeSeal tube 0.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058050SafeSeal tube 0.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058135SafeSeal tube 0.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058173SafeSeal tube 0.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058210Micro tube 0.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058296SafeSeal tube 1.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058340SafeSeal tube 1.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058388SafeSeal tube 1.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058425SafeSeal tube 1.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058463SafeSeal tube 1.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058500SafeSeal tube 1.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058548Micro tube 1.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916059354Faeces tube 101x16.5mmSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
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