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Sign in to claim this brandZhejiang Orient Gene Biotech Co., Ltd
China·CN-MF-000017965
Last updated June 8, 2026
Information
- Country
- China
- Address
- 3787#, East Yangguang Avenue, Dipu Street, Anji 313300, Huzhou,Zhejiang, China
- Website
- orientgene.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Joyce Pang
- EUDAMED SRN
- CN-MF-000017965
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (435)
Page 1 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| One Step Opiate Test Strip (Urine) | GBOPI-101a | EUDAMED | IVD General | Active |
| CT Control | FDCT-PN20 | EUDAMED | IVD General | Active |
| Oral Fluid Drug Test Device | GBDSA-XXXXMX | EUDAMED | IVD General | Active |
| LH Quantitative Test Kit (Time-Resolved FIA) | FALH-402a | EUDAMED | IVD General | Active |
| cTnl/ Myo/ CK-MB Control | FDCAR-PN20 | EUDAMED | IVD General | Active |
| One Step Tramadol Test Strip (Urine) | GBTRA-101a | EUDAMED | IVD General | Active |
| One Step Methcathinone Test Cassette (Urine) | GBMTC-102a | EUDAMED | IVD General | Active |
| SHBG Quantitative Test Kit (Time-Resolved FIA) | FKSHB-402a | EUDAMED | IVD General | Active |
| TES Control | FKTES-PN20 | EUDAMED | IVD General | Active |
| Herpes Simplex VirusⅠDetection Kit (Fluorescence PCR) | AHSV101-AOG48E; AHSV101-AOG96E; AHSV101D-AOG48E; AHSV101D-AOG96E | EUDAMED | IVD General | Active |
| In vitro Diagnostic Kit for Creatine Kinase-MB (Chemiluminescence Assay) | 1CKMBB11 | EUDAMED | IVD General | Active |
| D-Dimer Quantitative Test Kit (Time-Resolved FIA) | FDDDI-402a | EUDAMED | IVD General | Active |
| TSH Quantitative Test Kit (Time-Resolved FIA) | FKTSH-402a | EUDAMED | IVD General | Active |
| Neisseria Gonorrhoeae Detection Kit (Fluorescence PCR) | ANG01-AOG48E;,ANG01-AOG96E,ANG01D-AOG48E, ANG01D-AOG96E | EUDAMED | IVD General | Active |
| Human Papillomavirus (18 types) Genotyping Kit (Melt-Fluorescence PCR) | AHPV1801-BOG48E，AHPV1801-BOG96E | EUDAMED | IVD General | Active |
| SHBG Control | FKSHB-PN20 | EUDAMED | IVD General | Active |
| T4 Control | FKTT4-PN20 | EUDAMED | IVD General | Active |
| One Step Oxycodone Test Cassette (Urine) | GBOXY-102a | EUDAMED | IVD General | Active |
| Oral Fluid Drug Test Cube | GBDSA-XXXXFSI | EUDAMED | IVD General | Active |
| AFP Control | FEAFP-PN20 | EUDAMED | IVD General | Active |
| Nucleic Acid Extraction or Purification Kit | SNCE05-BOG48E | EUDAMED | IVD General | Active |
| PROG Quantitative Test Kit (Time-Resolved FIA) | FAPRO-402a | EUDAMED | IVD General | Active |
| TSH Quantitative Test Kit (Time-Resolved FIA) | FKTSH-402b | EUDAMED | IVD General | Active |
| β-hCG Quantitative Test Kit (Time-Resolved FIA) | FAHCG-402a | EUDAMED | IVD General | Active |
| Oral Fluid Drug Test Cube | GBDSA-XXXXFX | EUDAMED | IVD General | Active |
| β2-MG Quantitative Test Kit (Time-Resolved FIA) | FIMG-402a | EUDAMED | IVD General | Active |
| Myo Control | FDMYO-PN20 | EUDAMED | IVD General | Active |
| Vitamin D Quantitative Test Kit (Time-Resolved FIA) | FIVD-402a | EUDAMED | IVD General | Active |
| Human Parainfluenza Virus Type Ⅰ/Ⅲ &Adenovirus Detection Kit (Fluorescence PCR) | APA01-AOG48E; APA01-AOG96E; APA01D-AOG48E; APA01D-AOG96E | EUDAMED | IVD General | Active |
| SAA Control | FDSAA-PN20 | EUDAMED | IVD General | Active |
| Beta-HCG Control | FAHCG-PN20 | EUDAMED | IVD General | Active |
| One Step Methaqualone Test Strip (Urine) | GBMQL-101a | EUDAMED | IVD General | Active |
| One Step EDDP Test Cassette (Urine) | GBEDD-102a | EUDAMED | IVD General | Active |
| PCT / IL-6 Quantitative Test Kit (Time-Resolved FIA) | FDPI-T402a | EUDAMED | IVD General | Active |
| Flu A Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) | FCFLU(A)-502a | EUDAMED | IVD General | Active |
| Oral Fluid Drug Test Cylinder | GBDSA-XXXXCX | EUDAMED | IVD General | Active |
| In vitro Diagnostic Kit for Myoglobin (Chemiluminescence Assay) | 1MYOB12 | EUDAMED | IVD General | Active |
| Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) | FCADE-502Ca | EUDAMED | IVD General | Active |
| RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab) | FCRA-T502a | EUDAMED | IVD General | Active |
| PCT Control | FDPCT-PN20 | EUDAMED | IVD General | Active |
| One Step Ketamine Test Cassette (Urine) | GBKET-102a | EUDAMED | IVD General | Active |
| Dengue Virus Detection Kit (Fluorescence PCR) | ADV01-AOG48E;,ADV01-AOG96E,ADV01D-AOG48E,ADV01D-AOG96E | EUDAMED | IVD General | Active |
| PTH Quantitative Test Kit (Time-Resolved FIA) | FKPTH-402a | EUDAMED | IVD General | Active |
| Oral Fluid Drug Test | GBDSA-XXXXEX | EUDAMED | IVD General | Active |
| Free T4 Quantitative Test Kit (Time-Resolved FIA) | FKFT4-402a | EUDAMED | IVD General | Active |
| Oral Fluid Drug Test Kit (FIA) | FBxxx-702a | EUDAMED | IVD General | Active |
| CEA Control | FECEA-PN20 | EUDAMED | IVD General | Active |
| PRL Quantitative Test Kit (Time-Resolved FIA) | FAPRL-402a | EUDAMED | IVD General | Active |
| One Step Norfentanyl Test Strip (Urine) | GBNFT-101c | EUDAMED | IVD General | Active |
| HPIV Antigen Rapid Test Kit (Time-Resolved FIA) | FCHPIV-502a | EUDAMED | IVD General | Active |
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