COVID-19 Neutralization Antibody IFU version 2021-01

by Gold Probe Diagnostic Biotechnology Inc. MF China EUDAMED

Ref 600110 EMDN W0105099099

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06975977071107 Basic UDI-DI	Date19 Dec 2023Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: COVID-19 Neutralization Antibody IFU version 2021-01
Model / Reference: 600110

Primary DI / UDI-DI: 06975977071107
Basic UDI-DI: B-06975977071107
EMDN Code: W0105099099 Virology - rt & poc - other

Device Class: Class IVD General
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000031524
Authorised representative: Lotus NL B.V. NL-AR-000000121

Other devices from Gold Probe Diagnostic Biotechnology Inc. MF

Lung Cancer Mutant Genes Detction Panel (Multiplex Real-time PCR)

IVD General
BRAF V600E/D/R/K Mutations Detection Kit （Multiplex Real-time PCR）

IVD General
Real time RT-PCR Kit for SARS-2 Flu A Flu B

IVD General
TERT Promoter Mutation Detection Kit（Real-time PCR Assays）

IVD General
Real-Time PCR Kit for Detection of SARS-CoV-2

IVD General
Neisseria Gonorrhoeae/Chlamydia Trachomatis/U. Urealyticum Real Time PCR Kit

IVD General

See all devices from Gold Probe Diagnostic Biotechnology Inc. MF →

Properties & raw data

Show properties, registry sources and raw records

Reagent
Near-Patient Testing
Professional Testing

Other properties (7)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED 8aa55dcd-35a5-4a9e-89f1-172cbd19b11f 61 fields · synced 22 Oct 2026