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EUDAMED last updated this device on May 11, 2026
B-GCADE-PN23KAdenovirus Antigen Control Kit is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhejiang Orient Gene Biotech Co., Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-GCADE-PN23KB-GCADE-PN23KGCADE-PN2D-GCADE-PN23K
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105080804OTHER VIROLOGY CONTROLS - INF.IMM.3 warnings recorded — scroll inside the panel to see all entries.
CW010CW009CW007No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market |
CN-MF-000017965Certificate health across this manufacturer's portfolio.
CR-04-1249-874-25SupplementedCR-04-1249-875-25IssuedB-FIVD-PN20E5On the marketAdenovirus Antigen FIA Control KitB-FCADE-PN22UOn the marketAdenovirus Antigen Fluorescence Rapid Test Cassette (Swab)B-FCADE-502aMCOn the marketAdenovirus Antigen Fluorescence Rapid Test Cassette (Swab)B-FCADE-502CaENOn the marketAFP ControlB-FEAFP-PN203XOn the market