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Abbott Diagnostics Technologies AS

US

Last updated May 30, 2026

Part of Abbott Diagnostics Technologies AS

Information

Country: US
Address: —
Website: xx.xx
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-866-216-9505
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 515324122

Catalogue (17)

Device	Model / Reference	Registries	Class	Status
Afinion HbA1c	1116974	FDA UDI	Class II	Active
Afinion HbA1c Calibration Verification	1116792	FDA UDI	Class I	Active
Afinion™ 2	1116970	FDA UDI	Class I	Active
Afinion ACR	1116972	FDA UDI	Class II	Active
Alere Afinion HbA1c Control	1115178	FDA UDI	Class I	Active
Afinion™ 2	1116971	FDA UDI	Class I	Active
Afinion ACR Control	1116973	FDA UDI	Class I	Active
Afinion HbA1c Calibration Verification	1116792	FDA UDI	Class I	Active
Alere Afinion™ AS100	1115390	FDA UDI	Class I	Active
Afinion HbA1c Dx	1116482	FDA UDI	Class II	Unknown
Afinion™ 2	1116985	FDA UDI	Class I	Active
Alere Afinion™ HbA1c	1115015	FDA UDI	Class II	Active
Alere Afinion ACR Control	1115239	FDA UDI	N/A	Active
Afinion HbA1c Dx	1116794	FDA UDI	Class II	Active
Afinion HbA1c Control	1116975	FDA UDI	Class I	Active
Afinion™ 2	1116986	FDA UDI	Class I	Active
Alere Afinion™ ACR	1115020	FDA UDI	Class II	Active

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