Data from EUDAMED, last updated Jun 11, 2026

Hemoglobin A1c Test Kit (Boronate Fluorescence Quenching Technology)

B-06938384631111

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: Labnovation Technologies, Inc.

Device family identification

Device name: Hemoglobin A1c Test Kit (Boronate Fluorescence Quenching Technology)
Basic UDI-DI: B-06938384631111
Device model: 50 Tests/Box
Issuing agency: EUDAMED
Version date: May 21, 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
Hemoglobin A1c Test Kit (Boronate Fluorescence Quenching Technology)	`L-100102`	`06938384631111`	1	On the market