- Role
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- Date of registration
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EUDAMED last updated this device on Mar 30, 2026
B-GCCOV(NAb)-402bHGN8SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Healgen Scientific Limited Liability Company. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
US-MF-000018839D-GCCOV(NAb)-402bHGN8
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
3 warnings recorded — scroll inside the panel to see all entries.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-GCCOV(NAb)-402bHGN8Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-GCCOV(NAb)-402bHGN8GCCOV(NAb)-402bUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090502CORONAVIRUS ANTIBODY (AB) - RT & POCPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.B-FCFC-T502aHGRROn the marketSARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)B-FCCOV-502aHG3BOn the marketSARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab)B-GCCOV(Del)-T502aHGQGOn the marketSHBG ControlB-FKSHB-PN20HGNGOn the marketSHBG Quantitative Test Kit (Time-Resolved FIA)B-FKSHB-402aHG89On the marketSmart Rapid COVID-19 & Flu A/B Ag Test DeviceB-GCFC-T503aHGT5On the market