Skip to content

Anti-streptolysin O Assay Kit (Immunoturbidimetric Method)

by Da Te Bioengineering Technology Co., LTD. EUDAMED

Active European Union

Ref DTSH090107Model R1: 60 mL×1; R2: 15 mL×1

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975225461773 Basic UDI-DIDate10 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Anti-streptolysin O Assay Kit (Immunoturbidimetric Method)
Model / Reference
R1: 60 mL×1, R2: 15 mL×1, DTSH090107
Primary DI / UDI-DI
06975225461773
Basic UDI-DI
B-06975225461773
EMDN Code
W01021104 Anti-streptolysin o (quantitative)
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000028832
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Da Te Bioengineering Technology Co., LTD.

See all devices from Da Te Bioengineering Technology Co., LTD. →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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