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TargetingOne Technology (Beijing) Corporation

China·CN-MF-000028247

Last updated June 8, 2026

Information

Country: China
Address: Building No.8, No.1 Chaoqian Road, Science and Technology Park Zone, Changping District,, Beijing, China
Website: targetingone.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Na Gao
EUDAMED SRN: CN-MF-000028247
FDA FEI Number: —
DUNS Number: 541198269

Catalogue (151)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
EZH2 mutation digital PCR detection kit	12642-1	EUDAMED	IVD General	Active
BCR-ABL p210 digital PCR detection kit	12901-2	EUDAMED	IVD General	Active
ESR1 mutation digital PCR detection kit	12644-1	EUDAMED	IVD General	Active
BCR-ABL p190/p210/p230 digital PCR detection kit	12946-1	EUDAMED	IVD General	Active
Cervical cancer-associated gene methylation digital PCR detection kit	12919-2	EUDAMED	IVD General	Active
Urothelial carcinoma-associated gene methylation digital PCR detection kit	12918-2	EUDAMED	IVD General	Active
Meningitis/Encephalitis (ME) pathogens digital PCR detection kit	13699-1	EUDAMED	IVD General	Active
Digital PCR Universal Kit	10132	EUDAMED	Class A	Active
MELAS genetic mutation digital PCR detection kit	13309-1	EUDAMED	IVD General	Active
Meningitis/Encephalitis (ME) pathogens digital PCR detection kit	13699-2	EUDAMED	IVD General	Active
Targetingone	Nucleic acid extraction reagent/ Pathogens TNA-P2	FDA UDI	Class I	Active
Targetingone	Nucleic acid extraction reagent (Cell DNA)/ CELL DNA-P1, Specification: 64 tests	EUDAMEDFDA UDI	Class I	Active
Targetingone	Nucleic acid release reagent/easyTNA -B1	EUDAMEDFDA UDI	Class I	Active
Targetingone	Nucleic acid extraction reagent (cfDNA)	FDA UDI	Class I	Active
Targetingone	Nucleic acid release agent (DNA)/easyDNA -B1	FDA UDI	Class I	Active
Targetingone	Nucleic acid extraction reagent/B1	FDA UDI	Class I	Active
Targetingone	Nucleic acid release reagent/easyTNA -T1	EUDAMEDFDA UDI	Class I	Active
Targetingone	Nucleic acid extraction reagent (FFPE TNA)/FFPE TNA-P2	EUDAMEDFDA UDI	Class I	Active
Targetingone	Nucleic acid extraction reagent (Virus TNA)/P2	FDA UDI	Class I	Active
Targetingone	Digital PCR analysis System/D2	FDA UDI	Class II	Active
Targetingone	Saliva collection kit/T1	EUDAMEDFDA UDI	Class I	Active
Targetingone	Nucleic acid release agent (DNA)/easyDNA -T1	FDA UDI	Class I	Active
Targetingone	Nucleic acid extraction reagent (Virus TNA)/P3	FDA UDI	Class I	Active
Targetingone	Digital PCR analysis System/D1	FDA UDI	Class II	Active
Targetingone	Nucleic acid extraction reagent/ Pathogens TNA-P1	EUDAMEDFDA UDI	Class I	Active
Targetingone	Nucleic acid extraction reagent (Virus TNA)/P1	FDA UDI	Class I	Active
Targetingone	Nucleic acid extraction reagent/ Pathogens TNA-B1	EUDAMEDFDA UDI	Class I	Active
Targetingone	Nucleic acid extraction reagent (Virus TNA)/B1	FDA UDI	Class I	Active
Targetingone	Nucleic acid extraction reagent/P1	FDA UDI	Class I	Active
Nucleic acid extraction reagent (cfDNA)	11114-11116	EUDAMEDFDA UDI	Class A	Active
ALK/ROS1/MET gene fusions and mutations real-time PCR detection kit	"Model: AR02-2Y24; Specification: 24 Tests Model: AR02-1Y24; Specification: 24 Tests"	EUDAMED	IVD General	Active
SARS-CoV-2 Antigen Test	SCAg-1，SCAg-5， SCAg-25，SCAg02-1，SCAg02-5，SCAg02-25	EUDAMED	IVD General	Active
E10 Nucleic Acid Extraction System	48031	EUDAMEDFDA UDI	Class A	Active
Saliva collection kit	N/A	EUDAMED	Class A	Active
Lung cancer digital PCR panel	"Model: LC01-Q12, Specification: 12 Tests Model: LC01-Y12, Specification: 12 Tests"	EUDAMED	IVD General	Active
PIK3CA mutation digital PCR detection kit	Model: PI01-Q24; Specification: 24 Tests Model: PI01-Y24; Specification: 24 Tests	EUDAMED	IVD General	Active
Dengue Antigen Rapid Test	Model: DEAg-25; Specification: 25 Tests	EUDAMED	IVD General	Active
Drop Maker	N/A	EUDAMEDFDA UDI	Class A	Active
Nucleic acid release reagent	N/A	EUDAMED	Class A	Active
Genitourinary pathogen nucleic acid real-time PCR detection kit	"Model: NM01-2Y32; Specification: 32Tests Model: NM01-1Y32; Specification: 32Tests"	EUDAMED	IVD General	Active
Colorectal cancer methylation real-time PCR panel	"Model: CM02-2Y24; Specification: 24 Tests Model: CM02-1Y24; Specification: 24 Tests"	EUDAMED	IVD General	Active
EBV nucleic acid digital PCR detection kit	"Model: EB01-Q24, Specification: 24 Tests Model: EB01-Y24, Specification: 24 Tests"	EUDAMED	IVD General	Active
Gonorrhoeae Antigen Rapid Test	Model: NGAg-25; Specification: 25 Tests / Kit	EUDAMED	IVD General	Active
FGFR gene fusions and mutation digital PCR detection kit	"Model: FG01-Q24; Specification: 24 Tests Model: FG01-Y24; Specification: 24 Tests"	EUDAMED	IVD General	Active
Fecal Occult Blood Rapid Test	"Model: FOBT-1; Specification: 1 Test Model: FOBT-5; Specification: 5 Tests Model: FOBT-25; Specification: 25 Tests"	EUDAMED	IVD General	Active
JCV/BKV nucleic acid digital PCR detection kit	"Model: JB01-Q24; Specification: 24 Tests Model: JB01-Y24; Specification: 24 Tests"	EUDAMED	IVD General	Active
Human adenovirus nucleic acid real-time PCR detection kit	"Model: AD01-2Y32; Specification: 32 Tests Model: AD01-1Y32; Specification: 32 Tests"	EUDAMED	IVD General	Active
D20 Automatic Digital PCR System	NA	EUDAMED	Class A	Active
Nucleic acid extraction reagent	52521	EUDAMED	Class A	Active
C6 easyPCR Analyzer	48031	EUDAMEDFDA UDI	Class A	Active

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