Data from EUDAMED, last updated Jun 11, 2026

ANTI-STREPTOLYSIN O KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

B-06942202212918

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: DIRUI INDUSTRIAL CO., LTD

Device family identification

Device name: ANTI-STREPTOLYSIN O KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）
Basic UDI-DI: B-06942202212918
Device model: R1: 1x40mL, R2: 1x10mL, Calibration sample: 1x1mL,
Issuing agency: EUDAMED
Version date: May 12, 2026

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Status: On the market

ReagentProfessional testing

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

References

1 reference

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
ANTI-STREPTOLYSIN O KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）	`3023200`	`06942202212918`	1	On the market