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Streptococcus Group B antisera

by Genhawk (Wuhan) Biotech Co., Ltd. 10 variants

Ref Streptococcus Group B Type antisera（Type V）, Streptococcus Group B latex antisera（Type VI）, Streptococcus Group B antisera for quality control（Type Ib）, Streptococcus Group B latex antisera（Type VII）, Streptococcus Group B antisera for quality control（Type V）, Streptococcus Group B Type antisera（Type VII）, Streptococcus Group B latex antisera（Type IX）, Streptococcus Group B antisera for quality contro（Type VIII）, Streptococcus Group B Type antisera（Type VI）, Streptococcus Group B antisera for quality control (Type Ia), Streptococcus Group B antisera for quality control（Type IV）, Streptococcus Group B latex antisera（Type Ib）, Streptococcus Group B Type antisera (Type Ia), Streptococcus Group B antisera for quality control（Type VI）, Streptococcus Group B Type antisera（Type VIII）, Streptococcus Group B Type antisera（Type II）, Streptococcus Group B antisera for quality control（Type IX）, Streptococcus Group B Type antisera（Type Ib）, Streptococcus Group B latex antisera（Type II）, Streptococcus Group B Type antisera（Type IX）, Streptococcus Group B latex antisera（Type III）

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977597620055 Basic UDI-DI Date9 Jul 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Streptococcus Group B antisera
Model / Reference
Streptococcus Group B Type antisera（Type V）, Streptococcus Group B latex antisera（Type VI）, Streptococcus Group B antisera for quality control（Type Ib）, Streptococcus Group B latex antisera（Type VII）, Streptococcus Group B antisera for quality control（Type V）, Streptococcus Group B Type antisera（Type VII）, Streptococcus Group B latex antisera（Type IX）, Streptococcus Group B antisera for quality contro（Type VIII）, Streptococcus Group B Type antisera（Type VI）, Streptococcus Group B antisera for quality control (Type Ia), Streptococcus Group B antisera for quality control（Type IV）, Streptococcus Group B latex antisera（Type Ib）, Streptococcus Group B Type antisera (Type Ia), Streptococcus Group B antisera for quality control（Type VI）, Streptococcus Group B Type antisera（Type VIII）, Streptococcus Group B Type antisera（Type II）, Streptococcus Group B antisera for quality control（Type IX）, Streptococcus Group B Type antisera（Type Ib）, Streptococcus Group B latex antisera（Type II）, Streptococcus Group B Type antisera（Type IX）, Streptococcus Group B latex antisera（Type III）
Primary DI / UDI-DI
06977597620055, 06977597620161, 06977597620215, 06977597620178, 06977597620253, 06977597620079, 06977597620192, 06977597620284, 06977597620062, 06977597620208, 06977597620246, 06977597620116, 06977597620000, 06977597620260, 06977597620086, 06977597620024, 06977597620291, 06977597620017, 06977597620123, 06977597620093, 06977597620130
Basic UDI-DI
B-06977597620055, B-06977597620161, B-06977597620215, B-06977597620178, B-06977597620253, B-06977597620079, B-06977597620192, B-06977597620284, B-06977597620062, B-06977597620208, B-06977597620246, B-06977597620116, B-06977597620000, B-06977597620260, B-06977597620086, B-06977597620024, B-06977597620291, B-06977597620017, B-06977597620123, B-06977597620093, B-06977597620130
EMDN Code
W0105011101, W0105011102, W0105011103, W0105011104, W0105011105, W0105011199
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000042707
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No