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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 8 of 9

Device	Model / Reference	Registries	Class	Status
QUANTA Flash	701116	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701138	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701356	EUDAMED	IVD General	Active
QUANTA Flash	701243	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701125	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701135	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701161	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701127	EUDAMEDFDA UDI	IVD General	Active
QUANTA Lite	708785	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	708290	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701177	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701188	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701331	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701258	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701327	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701366	EUDAMED	IVD General	Active
QUANTA Flash	701142	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701367	EUDAMED	IVD General	Active
QUANTA Flash	701122	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701332	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701141	EUDAMEDFDA UDI	IVD General	Active
QUANTA Lite	708520	EUDAMEDFDA UDI	IVD General	Active
Aptiva® Optical Control Kit	AC1002	EUDAMEDFDA UDI	Class A	Active
QUANTA Flash	701106	EUDAMEDFDA UDI	IVD General	Active
Aptiva	723102	EUDAMEDFDA UDI	IVD General	Active
Aptiva® System Rinse	AC1004	EUDAMEDFDA UDI	Class A	Active
Aptiva® APS IgG Reagent	725100	EUDAMEDFDA UDI	Class B	Active
QUANTA Flash	701250	EUDAMEDFDA UDI	IVD General	Active
Aptiva® CTD Essential Calibrators	723101	EUDAMEDFDA 510(k)FDA UDI	Class B	Active
Aptiva Instrument System Cuvettes	AC1005	EUDAMEDFDA UDI	Class A	Active
QUANTA Flash	701232	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701192	EUDAMED	IVD General	Active
NOVA Lite	704265	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701118	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701060	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701153	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701266	EUDAMED	IVD General	Active
QUANTA Flash	701146	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite® IFA Hu (ANNA-1) Positive Control	704073	EUDAMED	Class B	Active
QUANTA Flash	701133	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	708100	EUDAMEDFDA UDI	IVD General	Active
QUANTA-Lyser® 3000 ELISA/IFA + Incubator	VS3000i	EUDAMEDFDA UDI	Class A	Active
QUANTA Flash	701248	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite® IFA Pancreatic Islet Cell Positive Control	704005	EUDAMED	Class B	Active
QUANTA-Lyser® 3000 IFA	VS3002	EUDAMEDFDA UDI	Class A	Active
Aptiva	723100	EUDAMEDFDA 510(k)FDA UDI	IVD General	Active
QUANTA Flash	701178	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701263	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	704155	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701298	EUDAMEDFDA UDI	IVD General	Active

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