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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 6 of 9

Device	Model / Reference	Registries	Class	Status
Quanta Flash (tm) Dgp Screen	K111414	FDA 510(k)	Class II	Active
Quanta Flash H-Ttg Igg	K101644	FDA 510(k)	Class II	Active
Quanta Lite Mpo Igg (myeloperoxidase) Test Kit	K981330	FDA 510(k)	Class II	Active
Quanta Lite Ccp Elisa	K020414	FDA 510(k)	Class II	Active
Quanta Lite Gp210 Elisa	K040885	FDA 510(k)	Class II	Active
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols	K151429	FDA 510(k)	Class II	Active
Quanta Flash Dgp Iga, Quanta Flash Dgp Igg, Quanta Flash Dgp Iga Calibrators, Quanta Flash Dgp Igg Calibrators	K113863	FDA 510(k)	Class II	Active
Quanta Plex Anca Profile	K050715	FDA 510(k)	Class II	Active
Quanta Lite Celiac Screen (tissue Transglutaminase/Gliadin) Elisa	K984137	FDA 510(k)	Class II	Active
Quanta Lite Ss-A 52 Elisa	K063565	FDA 510(k)FDA UDI	Class II	Active
Quanta Plex Celiac Iga Profile	K063818	FDA 510(k)	Class II	Active
Nova Gel(tm) T Scl-70	K896461	FDA 510(k)	Class II	Active
Quanta Lite Rnp Elisa	K922833	FDA 510(k)	Class II	Active
QUANTA Lite	708750	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701101	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701121	EUDAMEDFDA UDI	IVD General	Active
Aptiva® Optical Cleaning Solution	AC1003	EUDAMEDFDA UDI	Class A	Active
QUANTA Flash	701365	EUDAMED	IVD General	Active
QUANTA Flash	701351	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701166	EUDAMEDFDA UDI	IVD General	Active
QUANTA Lite	708845	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	704338	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite	704337	EUDAMEDFDA UDI	IVD General	Active
Aptiva Celiac Disease IgA Reagent	724120	EUDAMEDFDA UDI	Class B	Active
NOVA Lite	704150	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701350	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701152	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701245	EUDAMEDFDA UDI	IVD General	Active
QUANTA Lite	708870	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701301	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701252	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701333	EUDAMEDFDA UDI	IVD General	Active
Aptiva® APS IgG Calibrators	725101	EUDAMEDFDA UDI	Class B	Active
QUANTA Flash	701354	EUDAMEDFDA UDI	IVD General	Active
Aptiva® Optical Calibrator Kit	AC1001	EUDAMEDFDA UDI	Class A	Active
QUANTA Flash	701345	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701168	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701100	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701163	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701176	EUDAMEDFDA UDI	IVD General	Active
NOVA Lite® IFA Yo (PCA-1) Positive Control	704009	EUDAMED	Class B	Active
NOVA Lite	708200	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701261	EUDAMEDFDA UDI	IVD General	Active
QUANTA Flash	701198	EUDAMEDFDA UDI	IVD General	Active
Aptiva Celiac Disease IgA Control	724122	EUDAMEDFDA UDI	Class B	Active
QUANTA Flash	701162	EUDAMEDFDA UDI	IVD General	Active
QUANTA Lite	704535	EUDAMEDFDA UDI	IVD General	Active
Aptiva® APS IgM Controls	725142	EUDAMEDFDA UDI	Class B	Active
QUANTA Flash	701268	EUDAMED	IVD General	Active
Aptiva® APS IgM Reagent	725140	EUDAMEDFDA UDI	Class B	Active

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Medical Technology Promedt Consulting GmbH DE

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