DENV/ZIKV/CHIKV/OROV/MAYV Fluorescence PCR Kit (Lyophilized)
by Healgen Scientific Limited Liability Company
Ref ADZCOM01D-AHG48E
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-81649002ADZCOM01D7667 D-81649002ADZCOM01D7667 | Date26 May 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- DENV/ZIKV/CHIKV/OROV/MAYV Fluorescence PCR Kit (Lyophilized)
- Model / Reference
- ADZCOM01D-AHG48E
- Primary DI / UDI-DI
- D-81649002ADZCOM01D7667
- Basic UDI-DI
- B-81649002ADZCOM01D7667
- EMDN Code
- W0105900102 Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus
- Device Class
- Class IVD General
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000018839
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No