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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 1 of 9
DeviceModel / ReferenceRegistriesClassStatus
QUANTA Lite® Gliadin IgA ELISA 708655
FDA UDI
Class IIActive
NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach 708155
FDA UDI
Class IIActive
QUANTA Lite® β2GPI IgG ELISA Bulk Pack 708665.10
FDA UDI
Class IIActive
QUANTA Lite® h-tTG /DGP Screen ELISA 704575
FDA UDI
Class IIActive
QUANTA Lite® dsDNA SC ELISA 704650
FDA UDI
Class IIActive
QUANTA Lite® ACA IgA III ELISA Bulk Pack 708635.10
FDA UDI
Class IIActive
QUANTA Lite® Phosphatidylserine IgG ELISA Bulk Pack 704625.10
FDA UDI
Class IIActive
QUANTA Lite® M2 EP (MIT3) ELISA Bulk Pack 704540.10
FDA UDI
Class IIActive
NOVA Gel® Scl-70 “S” Extractable Nuclear Autoantibody Reagents 708470
FDA UDI
Class IIUnknown
QUANTA Lite® ENA 4 ELISA 708555
FDA UDI
Class IIActive
QUANTA Lite® ACA IgA III 708635
FDA UDI
Class IIActive
QUANTA Lite® ACA IgG III ELISA Bulk Pack 708625.10
FDA UDI
Class IIActive
QUANTA Lite® ssDNA ELISA 708525
FDA UDI
Class IIUnknown
QUANTA LITE® ACA IgM III ELISA Bulk Pack Kit (Lab Corp) 708630.10L
FDA UDI
Class IIActive
QUANTA Lite® CCP3 IgG ELISA Bulk Pack 704535.10
FDA UDI
Class IIActive
QUANTA Lite® ENA 6 ELISA 708615
FDA UDI
Class IIActive
QUANTA Lite® Celiac DGP Screen ELISA 704545
FDA UDI
Class IIActive
QUANTA Flash® aCL IgA Reagents 701228
FDA UDI
Class IIActive
QUANTA Lite® h-tTG IgG ELISA Bulk Pack 708755.10
FDA UDI
Class IIActive
QUANTA Lite® ACA IgM III 708630
FDA UDI
Class IIActive
QUANTA LITE® R h-tTG IgG ELISA Bulk Pack (Lab Corp) 704610.10L
FDA UDI
Class IIActive
QUANTA Lite® gp210 ELISA 708995
FDA UDI
Class IIActive
QUANTA Lite® Calprotectin ELISA 704770
FDA UDI
Class IIActive
NOVA Gel® SS-A/SS-B “S” Extractable Nuclear Autoantibody Reagents 708450
FDA UDI
Class IIUnknown
QUANTA LITE® B2 GPI IgG ELISA Bulk Pack Kit (Lab Corp) 708665.10L
FDA UDI
Class IIActive
QUANTA Lite® ACA IgG III 708625
FDA UDI
Class IIActive
QUANTA Lite® β2GPI IgG ELISA 708665
FDA UDI
Class IIActive
NOVA Lite® ANCA Kit 708296
FDA UDI
Class IIActive
QUANTA Lite® R h-tTG IgA ELISA Bulk Pack 704605.10
FDA UDI
Class IIActive
QUANTA Lite® LKM- 1 ELISA 708745
FDA UDI
Class IIActive
QUANTA Lite® Phosphatidylserine IgM ELISA 704630
FDA UDI
Class IIActive
NOVA Gel® Sm/RNP “T” Extractable Autoantibody Reagents 708415
FDA UDI
Class IIUnknown
NOVA Lite® Auto AB Panel 708180
FDA UDI
Class IIActive
QUANTA LITE® B2 GPI IgA ELISA Bulk Pack Kit (Lab Corp) 708675.10L
FDA UDI
Class IIActive
QUANTA Lite® Actin IgG ELISA Bulk Pack 708785.10
FDA UDI
Class IIActive
QUANTA Lite® CCP3.1 IgG/IgA ELISA 704550
FDA UDI
Class IIActive
QUANTA Flash® Centromere Controls 701197
FDA UDI
Class IActive
QUANTA Lite® H.pylori IgA ELISA 708720
FDA UDI
Class IActive
QUANTA Lite® h-tTG IgG ELISA 708755
FDA UDI
Class IIActive
QUANTA Lite® Phosphatidylserine IgG ELISA 704625
FDA UDI
Class IIActive
QUANTA Lite® SLA ELISA 708775
FDA UDI
Class IIActive
NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach 708150
FDA UDI
Class IIActive
QUANTA Lite® RNP ELISA 708565
FDA UDI
Class IIActive
QUANTA Flash® DGP Screen Reagents 701113
FDA UDI
Class IIActive
QUANTA Lite® Gliadin IgA II ELISA 704525
FDA UDI
Class IIActive
QUANTA Flash® aCL IgM Controls 701237
FDA UDI
Class IActive
QUANTA Lite® MPO SC ELISA 704655
FDA UDI
Class IIActive
QUANTA Flash® β2GPI IgM Reagents 701253
FDA UDI
Class IIActive
NOVA Lite® ANA Kit with DAPI 708102
FDA UDI
Class IIUnknown
QUANTA Lite® Intrinsic Factor ELISA 708780
FDA UDI
Class IIActive

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