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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
—
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 2 of 9
DeviceModel / ReferenceRegistriesClassStatus
NOVA Gel® SS-A/SS-B “T” Extractable Nuclear AutoantibodyReagents 708455
FDA UDI
Class IIUnknown
QUANTA Lite® Gliadin IgG II ELISA Bulk Pack 704520.10
FDA UDI
Class IIActive
QUANTA Lite® ASCA IgG ELISA 708865
FDA UDI
Class IIActive
QUANTA LITE® ACA IgG III ELISA Bulk Pack Kit (Lab Corp) 708625.10L
FDA UDI
Class IIActive
QUANTA Lite® F-Actin IgA ELISA 704500
FDA UDI
Class IIActive
QUANTA Lite® RF IgG ELISA 708685
FDA UDI
Class IIActive
QUANTA Lite® RF IgA ELISA 708695
FDA UDI
Class IIActive
QUANTA Lite® MPO IgG ELISA 708700
FDA UDI
Class IIActive
QUANTA LITE® Gliadin IgG II ELISA Bulk Pack (Lab Corp) 704520.10L
FDA UDI
Class IIActive
QUANTA Lite® Jo-1 ELISA 708585
FDA UDI
Class IIActive
QUANTA Lite® Phosphatidylserine IgM ELISA Bulk Pack 704630.10
FDA UDI
Class IIActive
QUANTA Lite® R h-tTG IgG ELISA Bulk Pack 704610.10
FDA UDI
Class IIActive
QUANTA Lite® Scl-70 ELISA 708580
FDA UDI
Class IIActive
QUANTA Lite® TPO ELISA 708725
FDA UDI
Class IIActive
QUANTA Lite® PR-3 IgG ELISA 708705
FDA UDI
Class IIActive
QUANTA Lite® Phosphatidylserine IgA ELISA Bulk Pack 704635.10
FDA UDI
Class IIActive
QUANTA Flash® DGP IgG Controls 701172
FDA UDI
Class IActive
NOVA Lite® ANCA (Ethanol) Kit with DAPI 708301
FDA UDI
Class IIUnknown
QUANTA Lite® dsDNA ELISA 708510
FDA UDI
Class IIActive
QUANTA Lite® Centromere ELISA 708770
FDA UDI
Class IIActive
QUANTA Lite® Thyroid T ELISA 708595
FDA UDI
Class IIActive
QUANTA Flash® M2 (MIT3) Reagents 701303
FDA UDI
Class IIActive
QUANTA Lite® h-tTG Screen ELISA 704570
FDA UDI
Class IIActive
QUANTA Lite® H.pylori IgG ELISA 708715
FDA UDI
Class IActive
QUANTA Lite® β2GPI Screening ELISA 708660
FDA UDI
Class IIActive
QUANTA Lite® R h-tTG IgA ELISA 704605
FDA UDI
Class IIActive
QUANTA Flash® DGP IgA Controls 701167
FDA UDI
Class IActive
QUANTA Lite® tTG ELISA 708730
FDA UDI
Class IIActive
QUANTA Lite® M2 EP (MIT3) ELISA 704540
FDA UDI
Class IIActive
QUANTA Lite® CCP3.1 IgG/IgA ELISA Bulk Pack 704550.10
FDA UDI
Class IIActive
QUANTA Lite® RF IgM ELISA 708690
FDA UDI
Class IIActive
NOVA Gel® Jo-1 “T” Extractable Nuclear Autoantibody Reagents 708495
FDA UDI
Class IIUnknown
QUANTA Lite® ENA 5 ELISA 708610
FDA UDI
Class IIActive
NOVA Lite® dsDNA Crithidia Luciliae Kit with DAPI 708210
FDA UDI
Class IIUnknown
QUANTA Lite® sp100 ELISA 708990
FDA UDI
Class IIActive
QUANTA Lite® Phosphatidylserine IgA ELISA 704635
FDA UDI
Class IIActive
QUANTA Lite® GPA ELISA 708765
FDA UDI
Class IIActive
QUANTA Flash® DGP Screen Calibrators 701111
FDA UDI
Class IIActive
NOVA Lite® Thyroid 708350
FDA UDI
Class IIActive
NOVA Lite® HEp-2 External EB Kits 704230
FDA UDI
Class IIUnknown
QUANTA LITE® ACA IgA III ELISA Bulk Pack Kit (Lab Corp) 708635.10L
FDA UDI
Class IIActive
QUANTA Lite® MPO SC ELISA Bulk Pack 704655.10
FDA UDI
Class IIActive
QUANTA Lite® HA dsDNA ELISA 704615
FDA UDI
Class IIActive
QUANTA Lite® Gliadin IgA II ELISA Bulk Pack 704525.10
FDA UDI
Class IIActive
Fecal Extraction Device 504837
FDA UDI
Class IIActive
QUANTA Lite® GBM ELISA 708740
FDA UDI
Class IIActive
NOVA Lite® dsDNA Crithidia Luciliae 708205
FDA UDI
Class IIActive
QUANTA Lite® PBC Screen IgG/IgA ELISA 704560
FDA UDI
Class IIActive
QUANTA Lite® h-tTG IgA ELISA 708760
FDA UDI
Class IIActive
QUANTA LITE® Gliadin IgA II ELISA Bulk Pack Lab Corp 704525.10L
FDA UDI
Class IIActive

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