Data from EUDAMED, last updated May 23, 2026

Quantia Lp(a)

8436003070290XD

3 references

IVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class B
Manufacturer: Biokit S.A.

Device family identification

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class B
Status: On the market

ReagentProfessional testingAnimal tissues / cells

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

Data from EUDAMED, last updated May 23, 2026

8436003070290XD

3 references

IVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class B
Manufacturer: Biokit S.A.

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category: IVDR Class B
Status: On the market

ReagentProfessional testingAnimal tissues / cells

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

3 references

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
5P83-02	`5P83-02`	`00380740157432`	1	On the market
5P84-11	`5P84-11`	`00380740157449`	1	On the market
7K00-03	`7K00-03`	`00380740157494`	1	On the market