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INOVA DIAGNOSTICS, INC.

United States·US-MF-000017851

Last updated September 17, 2026

Information

Country: United States
Address: 9900, Old Grove Road, San Diego, United States
Website: werfen.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 858 586 9900 Ex. 77346
PRRC Contact: Frank Pokrop
EUDAMED SRN: US-MF-000017851
FDA FEI Number: 2026994
DUNS Number: —

Catalogue (404)

Page 7 of 9

Device	Model / Reference	Registries	Class	Status
QUANTA Flash	701137	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701346	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	708215	EUDAMEDFDA UDI	IVD General	Active
Aptiva	724102	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701225	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701328	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701296	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701171	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	708101	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701132	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701242	EUDAMEDFDA UDI	IVD General	Active
QUANTA Lite	708835	EUDAMEDFDA UDI	IVD General	Active
Aptiva Celiac Disease IgA Calibrators	724121	EUDAMEDFDA UDI	Class B	Active
QUANTA Flash	701257	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	708295	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701235	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701347	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701326	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701175	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701170	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701247	EUDAMEDFDA UDI	IVD General	Active
QUANTA Lite	708710	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	708380	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701196	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701173	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701131	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	708298	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701255	EUDAMEDFDA UDI	IVD General	Active
Aptiva Celiac Disease IgG Reagent	724100	EUDAMEDFDA UDI	Class B	Active
QUANTA Flash	701117	EUDAMEDFDA UDI	IVD General	Active
Aptiva Celiac Disease IgG Calibrators	724101	EUDAMEDFDA UDI	Class B	Active
QUANTA Flash	701148	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701302	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	704320	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	704170	EUDAMEDFDA UDI	IVD General	Active
QUANTA Lite	704555	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701103	EUDAMEDFDA UDI	IVD General	Active
NOVA View® AUTOLoader	ADLR1000	EUDAMEDFDA UDI	Class A	Active
NOVA Lite	704145	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701151	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701341	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701123	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	708297	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701126	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701107	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701130	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701352	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	708390	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701262	EUDAMEDFDA UDI	IVD General	Active
NOVA View® Automated Fluorescence Microscope	NV2000	EUDAMEDFDA UDI	Class A	Active

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Notified Bodies

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Authorities

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