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CLIA Borrelia CSF IgM

by TestLine Clinical Diagnostics s.r.o. EUDAMED

Active European Union

Ref CL-BCSFM50

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8595635312144BW Basic UDI-DIDate2 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
CLIA Borrelia CSF IgM
Model / Reference
CL-BCSFM50
Primary DI / UDI-DI
08595635312144
Basic UDI-DI
8595635312144BW
EMDN Code
W0105010604 Lyme antibody igm
Device Class
Class B
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000001803

From the manufacturer

Manufacturer's product page: BLOT-LINE Borrelia afzelii IgM

Other devices from TestLine Clinical Diagnostics s.r.o.

See all devices from TestLine Clinical Diagnostics s.r.o. →

Properties

Show properties
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No