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ALBA BIOSCIENCE LIMITED

United Kingdom (ex Northern Ireland)·GB-MF-000029300

Last updated September 17, 2026

Information

Country: United Kingdom (ex Northern Ireland)
Address: 5, James Hamilton Way, Milton Bridge, Penicuik, United Kingdom (ex Northern Ireland)
Website: www.alivedx.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 01313573333
PRRC Contact: VICTORIA VANHOUTTE
EUDAMED SRN: GB-MF-000029300
FDA FEI Number: 3011683976
DUNS Number: —

Catalogue (59)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
ALBAclone® Anti-D blend Monoclonal IgM/IgG	Z041	EUDAMED	IVD Annex II List A	Active
ALBAcheck® - BGS SIMULATED WHOLE BLOOD CONTROLS	Z489	EUDAMED	IVD Annex II List A	Active
ALBAcyte® Reagent Red Cells for Antibody Identification (papainised)	Z472	EUDAMED	IVD Annex II List B	Active
ORTHO™ Anti-Lea	6904497 (FD212B)	EUDAMED	IVD General	Active
ORTHO™ Sera Anti- Fya	6904486 (FD151B)	EUDAMED	IVD Annex II List B	Active
ALBAclone® Anti-Lea	Z212	EUDAMED	IVD General	Active
Monospecific Anti-Human IgG	Z356	EUDAMED	IVD Annex II List B	Active
ORTHO™ Sera Anti-K	6904492 (FD132B)	EUDAMED	IVD Annex II List A	Active
ALBAcheck® BGS AlbaSure Sensitivity Control Kit	Z250	EUDAMED	IVD Annex II List B	Active
ORTHO™ Anti-P1	6904496 (FD202B)	EUDAMED	IVD General	Active
ALBAclone® Anti-Fya	Z152	EUDAMED	IVD Annex II List B	Active
ALBAcheck® - BGS Anti-D 0.05 IU/mL	Z263	EUDAMED	IVD Annex II List B	Active
Anti-A1 LECTIN	Z241	EUDAMED	IVD General	Active
ALBAsera® Anti-s	Z186	EUDAMED	IVD General	Active
ALBAclone® Anti-human C3	Z360	EUDAMED	IVD General	Active
ORTHO™ Anti-Leb	6904498 (FD217B)	EUDAMED	IVD General	Active
ALBAclone® Anti-D optimum	Z039	EUDAMED	IVD Annex II List A	Active
ALBAclone® Anti-E	Z073	EUDAMED	IVD Annex II List A	Active
ALBAclone® Anti-Jka	Z162	EUDAMED	IVD Annex II List B	Active
ALBAcheck® - BGS High Titre Control Kit	Z257	EUDAMED	IVD General	Active
ALBAcyte® IgG Sensitised Reagent Red Cells	Z441	EUDAMED	IVD Annex II List B	Active
ALBAcheck® - BGS Reagent Control for Anti-D	Z271	EUDAMED	IVD Annex II List A	Active
ALBAcyte® RhD Negative CAT Reagent Red Cells for Antibody Screening	Z466	EUDAMED	IVD Annex II List B	Active
ALBAcyte® Reagent Red Cells A1	Z401	EUDAMED	IVD Annex II List A	Active
ORTHOTM Elution Kit	6324445	EUDAMED	Class B	Active
ALBAclone® Anti-S	Z182	EUDAMED	IVD General	Active
ORTHO™ Anti-N	6904495 (FD176B)	EUDAMED	IVD General	Active
ALBAclone® Anti-Jkb	Z166	EUDAMED	IVD Annex II List B	Active
Polyspecific Anti-Human Globulin Reagent	Z350	EUDAMED	IVD Annex II List B	Active
ALBAclone® Anti-M	Z171	EUDAMED	IVD General	Active
ALBAcyte® Reagent Red Cells for Antibody Screening,	Z451	EUDAMED	IVD Annex II List B	Active
ORTHO™ Sera Anti-Jkb	6904489 (FD166B)	EUDAMED	IVD Annex II List B	Active
ORTHO™ Sera Anti-D (IAT)	6904493 (FD041B)	EUDAMED	IVD Annex II List A	Active
ALBAclone® Anti-k (cellano)	Z137	EUDAMED	IVD General	Active
ALBAcyte® Reagent Red Cells for Antibody Identification (native)	Z471	EUDAMED	IVD Annex II List B	Active
ORTHO™ Sera Anti-M	6904494 (FD171B)	EUDAMED	IVD General	Active
ALBAsera® Anti-Wra	Z231	EUDAMED	IVD General	Active
ORTHO™ Sera Anti-Jka	6904488 (FD162B)	EUDAMED	IVD Annex II List B	Active
ALBAcheck® - BGS AB Serum (Human)	Z281	EUDAMED	IVD Annex II List B	Active
ORTHO™ Sera Reagent Control	6986728 (FD272B)	EUDAMED	IVD Annex II List A	Active
ALBAclone® Anti-B	Z011	EUDAMED	IVD Annex II List A	Active
ALBAcyte® Reagent Red Cells O rr	Z421	EUDAMED	IVD Annex II List A	Active
ALBAcyte® Reagent Red Cells A2	Z406	EUDAMED	IVD Annex II List A	Active
ALBAcyte® Reagent Red Cells O R1r	Z416	EUDAMED	IVD Annex II List A	Active
ALBAclone® Anti-A, B	Z021	EUDAMED	IVD Annex II List A	Active
ORTHO™ Sera Anti-D (DVI)	6904623 (FD039B)	EUDAMED	IVD Annex II List A	Active
ALBAcyte® Reagent Red Cells B	Z411	EUDAMED	IVD Annex II List A	Active
ALBAclone® Anti-D alpha	Z031	EUDAMED	IVD Annex II List A	Active
ALBAclone® Anti-Fyb	Z154	EUDAMED	IVD Annex II List B	Active
ALBAclone® Anti-Leb	Z217	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Alba Bioscience Limited US