Anti Streptolysin-O (ASO), 5 mL Latex, 1 mL Positive control, 1 mL Negative con…

EUDAMED

Class IVD General (EU MDR)

Ref 101-0216

by Chronolab Systems, S.L.

Identity

Trade Name: Anti Streptolysin-O (ASO), 5 mL Latex, 1 mL Positive control, 1 mL Negative control EUDAMED
Device Name: Anti Streptolysin-O (ASO), 5 mL Latex, 1 mL Positive control, 1 mL Negative control EUDAMED
Model / Reference: 101-0216 EUDAMED

Identifiers

Primary DI / UDI-DI: D-084360385635639GT EUDAMED
Basic UDI-DI: B-084360385635639GT EUDAMED
EMDN Code: W01021105 ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE) EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Anti Streptolysin-O (ASO), 5 mL Latex, 1 mL Positive control, 1 mL Negative con… by Chronolab Systems, S.L. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-084360385635639GT	Class IVD General	Active

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Manufacturer

Manufacturer: Chronolab Systems, S.L.
EUDAMED SRN: ES-MF-000017043

Sources (1)

EUDAMED 7aa881cd-69be-46d7-a87e-b4099d8d4141 61 fields · synced Jun 18, 2026