Manufacturer's Devices - INOVA Diagnostics

Address:




9900 Old Grove Road



San Diego

CA 92131

United States


Authorised Representative/ UK Responsible Person
Name: Werfen Ltd
Address:

712 The Quadrant Cavendish Avenue Birchwood Warrington WA3 6DE

Manchester

Manchester

WA3 6DE

England United Kingdom




Code/Term Type
Cell morphology analyser IVD manualCell morphology analyser IVD manualIVD General
Smooth muscle antibody IVD controlSmooth muscle antibody IVD controlIVD General
Multiple antinuclear antibody (ANA) screening IVD calibratorMultiple antinuclear antibody (ANA) screening IVD calibratorIVD General
Multiple antinuclear antibody (ANA) screening IVD controlMultiple antinuclear antibody (ANA) screening IVD controlIVD General
Beta-2-glycoprotein I antibody IVD controlBeta-2-glycoprotein I antibody IVD controlIVD General
Anticardiolipin antibody IVD controlAnticardiolipin antibody IVD controlIVD General
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD calibratorProteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD calibratorIVD General
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD controlProteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD controlIVD General
Jo-1 antibody IVD calibratorJo-1 antibody IVD calibratorIVD General
Jo-1 antibody IVD controlJo-1 antibody IVD controlIVD General
Double stranded DNA antibody (anti-dsDNA) IVD controlDouble stranded DNA antibody (anti-dsDNA) IVD controlIVD General
Gliadin antibody IVD calibratorGliadin antibody IVD calibratorIVD General
Gliadin antibody IVD controlGliadin antibody IVD controlIVD General
Polymyositis-scleroderma antibody (anti-PM-Scl) IVD calibratorPolymyositis-scleroderma antibody (anti-PM-Scl) IVD calibratorIVD General
Polymyositis-scleroderma antibody (anti-PM-Scl) IVD controlPolymyositis-scleroderma antibody (anti-PM-Scl) IVD controlIVD General
Scleroderma-70 antibody (anti-Scl-70) IVD calibratorScleroderma-70 antibody (anti-Scl-70) IVD calibratorIVD General
Scleroderma-70 antibody (anti-Scl-70) IVD controlScleroderma-70 antibody (anti-Scl-70) IVD controlIVD General
Rheumatoid factor IVD calibratorRheumatoid factor IVD calibratorIVD General
Rheumatoid factor IVD controlRheumatoid factor IVD controlIVD General
Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD calibratorMyeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD calibratorIVD General
Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD controlMyeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD controlIVD General
Human immunoglobulin A (IgA) animal conjugate antibody reagent IVDHuman immunoglobulin A (IgA) animal conjugate antibody reagent IVDIVD General
Human immunoglobulin G (IgG) animal conjugate antibody reagent IVDHuman immunoglobulin G (IgG) animal conjugate antibody reagent IVDIVD General
Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVDHuman immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVDIVD General
Microscopy mounting medium IVDMicroscopy mounting medium IVDIVD General
SSA/Ro antibody (Sjogren's antibody) IVD calibratorSSA/Ro antibody (Sjogren's antibody) IVD calibratorIVD General
SSA/Ro antibody (Sjogren's antibody) IVD controlSSA/Ro antibody (Sjogren's antibody) IVD controlIVD General
SSB/La antibody (Sjogren's antibody) IVD calibratorSSB/La antibody (Sjogren's antibody) IVD calibratorIVD General
SSB/La antibody (Sjogren's antibody) IVD controlSSB/La antibody (Sjogren's antibody) IVD controlIVD General
Double stranded DNA antibody (anti-dsDNA) IVD calibratorDouble stranded DNA antibody (anti-dsDNA) IVD calibratorIVD General
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD calibratorMultiple extractable nuclear antigen antibody (anti-ENA) screening IVD calibratorIVD General
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD controlMultiple extractable nuclear antigen antibody (anti-ENA) screening IVD controlIVD General
Smith antibody (anti-Sm) IVD calibratorSmith antibody (anti-Sm) IVD calibratorIVD General
Smith antibody (anti-Sm) IVD controlSmith antibody (anti-Sm) IVD controlIVD General
Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)Helicobacter pylori immunoglobulin G (IgG) antibody IVD kit enzyme immunoassay (EIA)IVD General
Calprotectin IVD calibratorCalprotectin IVD calibratorIVD General
Calprotectin IVD controlCalprotectin IVD controlIVD General
Complement component C1q IVD kit enzyme immunoassay (EIA)Complement component C1q IVD kit enzyme immunoassay (EIA)IVD General
Beta-2-microglobulin IVD kit chemiluminescent immunoassayBeta-2-microglobulin IVD kit chemiluminescent immunoassayIVD General
Multiple antinuclear antibody (ANA) screening IVD kit enzyme immunoassay (EIA)Multiple antinuclear antibody (ANA) screening IVD kit enzyme immunoassay (EIA)IVD General
Multiple antinuclear antibody (ANA) screening IVD kit multiplexMultiple antinuclear antibody (ANA) screening IVD kit multiplexIVD General
Multiple Coeliac disease-associated antibody IVD kit multiplexMultiple Coeliac disease-associated antibody IVD kit multiplexIVD General
Multiple Coeliac disease-associated antibody IVD calibratorMultiple Coeliac disease-associated antibody IVD calibratorIVD General
Multiple Coeliac disease-associated antibody IVD controlMultiple Coeliac disease-associated antibody IVD controlIVD General
Multiple diabetes mellitus-associated antibody IVD reagentMultiple diabetes mellitus-associated antibody IVD reagentIVD General
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD kit enzyme immunoassay (EIA)Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD kit enzyme immunoassay (EIA)IVD General
Adrenal antibody IVD reagentAdrenal antibody IVD reagentIVD General
Anticardiolipin antibody IVD kit enzyme immunoassay (EIA)Anticardiolipin antibody IVD kit enzyme immunoassay (EIA)IVD General
Beta-2-glycoprotein I antibody IVD kit enzyme immunoassay (EIA)Beta-2-glycoprotein I antibody IVD kit enzyme immunoassay (EIA)IVD General
Cyclic citrullinated peptide antibody (anti-CCP) IVD calibratorCyclic citrullinated peptide antibody (anti-CCP) IVD calibratorIVD General
Cyclic citrullinated peptide antibody (anti-CCP) IVD controlCyclic citrullinated peptide antibody (anti-CCP) IVD controlIVD General
Multiple antinuclear antibody (ANA) screening IVD kit fluorescent immunoassayMultiple antinuclear antibody (ANA) screening IVD kit fluorescent immunoassayIVD General
Multiple antinuclear antibody (ANA) screening IVD reagentMultiple antinuclear antibody (ANA) screening IVD reagentIVD General
Double stranded DNA antibody (anti-dsDNA) IVD kit fluorescent immunoassayDouble stranded DNA antibody (anti-dsDNA) IVD kit fluorescent immunoassayIVD General
Double stranded DNA antibody (anti-dsDNA) IVD reagentDouble stranded DNA antibody (anti-dsDNA) IVD reagentIVD General
Endomysium antibody (EMA) IVD kit fluorescent immunoassayEndomysium antibody (EMA) IVD kit fluorescent immunoassayIVD General
Endomysium antibody (EMA) IVD controlEndomysium antibody (EMA) IVD controlIVD General
Endomysium antibody (EMA) IVD reagentEndomysium antibody (EMA) IVD reagentIVD General
Gliadin antibody IVD kit chemiluminescent immunoassayGliadin antibody IVD kit chemiluminescent immunoassayIVD General
Glomerular basement membrane antibody (Goodpasture antibody) IVD kit enzyme immunoassay (EIA)Glomerular basement membrane antibody (Goodpasture antibody) IVD kit enzyme immunoassay (EIA)IVD General
Glomerular basement membrane antibody (Goodpasture antibody) IVD calibratorGlomerular basement membrane antibody (Goodpasture antibody) IVD calibratorIVD General
Glomerular basement membrane antibody (Goodpasture antibody) IVD controlGlomerular basement membrane antibody (Goodpasture antibody) IVD controlIVD General
Glomerular basement membrane antibody (Goodpasture antibody) IVD reagentGlomerular basement membrane antibody (Goodpasture antibody) IVD reagentIVD General
Intrinsic factor/parietal cell antibody IVD kit enzyme immunoassay (EIA)Intrinsic factor/parietal cell antibody IVD kit enzyme immunoassay (EIA)IVD General
Jo-1 antibody IVD kit enzyme immunoassay (EIA)Jo-1 antibody IVD kit enzyme immunoassay (EIA)IVD General
Liver-kidney microsome 1 antibody (anti-LKM1) IVD kit enzyme immunoassay (EIA)Liver-kidney microsome 1 antibody (anti-LKM1) IVD kit enzyme immunoassay (EIA)IVD General
Mitochondrial antibody M2 (anti-Mi2) IVD kit enzyme immunoassay (EIA)Mitochondrial antibody M2 (anti-Mi2) IVD kit enzyme immunoassay (EIA)IVD General
Mitochondrial antibody M2 (anti-Mi2) IVD controlMitochondrial antibody M2 (anti-Mi2) IVD controlIVD General
Myelin-associated glycoprotein antibody (anti-MAG) IVD reagentMyelin-associated glycoprotein antibody (anti-MAG) IVD reagentIVD General
Multiple myocardium antibody IVD reagentMultiple myocardium antibody IVD reagentIVD General
Nucleosomal antibody IVD kit enzyme immunoassay (EIA)Nucleosomal antibody IVD kit enzyme immunoassay (EIA)IVD General
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD kit fluorescent immunoassayMultiple anti-neutrophil cytoplasmic antibody (ANCA) IVD kit fluorescent immunoassayIVD General
Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD controlMultiple anti-neutrophil cytoplasmic antibody (ANCA) IVD controlIVD General
Intrinsic factor/parietal cell antibody IVD controlIntrinsic factor/parietal cell antibody IVD controlIVD General
Rheumatoid factor IVD kit enzyme immunoassay (EIA)Rheumatoid factor IVD kit enzyme immunoassay (EIA)IVD General
Rheumatoid factor IVD kit chemiluminescent immunoassayRheumatoid factor IVD kit chemiluminescent immunoassayIVD General
Ro52 antibody (anti-Ro52)/Trim21 antibody IVD calibratorRo52 antibody (anti-Ro52)/Trim21 antibody IVD calibratorIVD General
Ro52 antibody (anti-Ro52)/Trim21 antibody IVD controlRo52 antibody (anti-Ro52)/Trim21 antibody IVD controlIVD General
Scleroderma-70 antibody (anti-Scl-70) IVD kit enzyme immunoassay (EIA)Scleroderma-70 antibody (anti-Scl-70) IVD kit enzyme immunoassay (EIA)IVD General
SSA/Ro antibody (Sjogren's antibody) IVD kit enzyme immunoassay (EIA)SSA/Ro antibody (Sjogren's antibody) IVD kit enzyme immunoassay (EIA)IVD General
SSB/La antibody (Sjogren's antibody) IVD kit enzyme immunoassay (EIA)SSB/La antibody (Sjogren's antibody) IVD kit enzyme immunoassay (EIA)IVD General
Skeletal muscle antibody IVD controlSkeletal muscle antibody IVD controlIVD General
Skeletal muscle antibody IVD reagentSkeletal muscle antibody IVD reagentIVD General
Sm/RNP antibody IVD kit enzyme immunoassay (EIA)Sm/RNP antibody IVD kit enzyme immunoassay (EIA)IVD General
Sm/RNP antibody IVD calibratorSm/RNP antibody IVD calibratorIVD General
Sm/RNP antibody IVD controlSm/RNP antibody IVD controlIVD General
Sp-100 protein antibody IVD kit enzyme immunoassay (EIA)Sp-100 protein antibody IVD kit enzyme immunoassay (EIA)IVD General
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit enzyme immunoassay (EIA)Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD kit enzyme immunoassay (EIA)IVD General
Tissue transglutaminase antibody IVD kit enzyme immunoassay (EIA)Tissue transglutaminase antibody IVD kit enzyme immunoassay (EIA)IVD General
Tissue transglutaminase antibody IVD calibratorTissue transglutaminase antibody IVD calibratorIVD General
Tissue transglutaminase antibody IVD controlTissue transglutaminase antibody IVD controlIVD General
Yo antibody IVD reagentYo antibody IVD reagentIVD General
Multiple clinical chemistry analyser IVD laboratoryMultiple clinical chemistry analyser IVD laboratoryIVD General
Multiplex analyser IVD laboratory automatedMultiplex analyser IVD laboratory automatedIVD General
Immunohistochemistry conjugated secondary antibody IVDImmunohistochemistry conjugated secondary antibody IVDIVD General
Buffered sample diluent IVD manualBuffered sample diluent IVD manualIVD General
Tissue transglutaminase antibody IVD kit chemiluminescent immunoassayTissue transglutaminase antibody IVD kit chemiluminescent immunoassayIVD General
Anticardiolipin antibody IVD kit chemiluminescent immunoassayAnticardiolipin antibody IVD kit chemiluminescent immunoassayIVD General
Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD kit chemiluminescent immunoassayMyeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD kit chemiluminescent immunoassayIVD General
Glomerular basement membrane antibody (Goodpasture antibody) IVD kit chemiluminescent immunoassayGlomerular basement membrane antibody (Goodpasture antibody) IVD kit chemiluminescent immunoassayIVD General
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit chemiluminescent immunoassayProteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD kit chemiluminescent immunoassayIVD General
Jo-1 antibody IVD kit chemiluminescent immunoassayJo-1 antibody IVD kit chemiluminescent immunoassayIVD General
SSA/Ro antibody (Sjogren's antibody) IVD kit chemiluminescent immunoassaySSA/Ro antibody (Sjogren's antibody) IVD kit chemiluminescent immunoassayIVD General
Smith antibody (anti-Sm) IVD kit chemiluminescent immunoassaySmith antibody (anti-Sm) IVD kit chemiluminescent immunoassayIVD General
Scleroderma-70 antibody (anti-Scl-70) IVD kit chemiluminescent immunoassayScleroderma-70 antibody (anti-Scl-70) IVD kit chemiluminescent immunoassayIVD General
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD kit chemiluminescent immunoassayMultiple extractable nuclear antigen antibody (anti-ENA) screening IVD kit chemiluminescent immunoassayIVD General
Sm/RNP antibody IVD kit chemiluminescent immunoassaySm/RNP antibody IVD kit chemiluminescent immunoassayIVD General
Phosphatidylserine/prothrombin complex antibody IVD kit enzyme immunoassay (EIA)Phosphatidylserine/prothrombin complex antibody IVD kit enzyme immunoassay (EIA)IVD General
SSB/La antibody (Sjogren's antibody) IVD kit chemiluminescent immunoassaySSB/La antibody (Sjogren's antibody) IVD kit chemiluminescent immunoassayIVD General
Ro52antibody(anti-Ro52)/TRIM21antibodyIVD kit chemiluminescent immunoassayRo52antibody(anti-Ro52)/TRIM21antibodyIVD kit chemiluminescent immunoassayIVD General
RNA polymerase III antibody (anti-Pol III) IVD kit enzyme immunoassay (EIA)RNA polymerase III antibody (anti-Pol III) IVD kit enzyme immunoassay (EIA)IVD General
Glycoprotein-210 (gp210) antibody IVD kit enzyme immunoassay (EIA)Glycoprotein-210 (gp210) antibody IVD kit enzyme immunoassay (EIA)IVD General
Multiple antinuclear antibody (ANA) screening IVD kit chemiluminescent immunoassayMultiple antinuclear antibody (ANA) screening IVD kit chemiluminescent immunoassayIVD General
Ribosomal phosphoprotein antibody IVD kit chemiluminescent immunoassayRibosomal phosphoprotein antibody IVD kit chemiluminescent immunoassayIVD General
DoublestrandedDNAantibody (anti-dsDNA) IVD kit chemiluminescent immunoassayDoublestrandedDNAantibody (anti-dsDNA) IVD kit chemiluminescent immunoassayIVD General
Clinical specimen extraction buffer IVDClinical specimen extraction buffer IVDIVD General
Calprotectin IVD kit chemiluminescent immunoassayCalprotectin IVD kit chemiluminescent immunoassayIVD General
3-Hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody IVD kit chemiluminescent immunoassay3-Hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody IVD kit chemiluminescent immunoassayIVD General
Mitochondrial antibody M2 (anti-Mi2) IVD kit fluorescent immunoassayMitochondrial antibody M2 (anti-Mi2) IVD kit fluorescent immunoassayIVD General
Smooth muscle antibody IVD kit fluorescent immunoassaySmooth muscle antibody IVD kit fluorescent immunoassayIVD General
Smith antibody (anti-Sm) IVD kit enzyme immunoassay (EIA)Smith antibody (anti-Sm) IVD kit enzyme immunoassay (EIA)IVD General
Intrinsic factor/parietal cell antibody IVD kit fluorescent immunoassayIntrinsic factor/parietal cell antibody IVD kit fluorescent immunoassayIVD General
Skin antibody IVD kit fluorescent immunoassaySkin antibody IVD kit fluorescent immunoassayIVD General
Hu antibody (anti-Hu) IVD reagentHu antibody (anti-Hu) IVD reagentIVD General
Ri antibody (anti-Ri) IVD reagentRi antibody (anti-Ri) IVD reagentIVD General
Buffered sample diluent IVDBuffered sample diluent IVDIVD General
Multiple gastrointestinal disease marker IVD kit enzyme immunoassay (EIA)Multiple gastrointestinal disease marker IVD kit enzyme immunoassay (EIA)IVD General
Optical laboratory instrument performance standard calibrator/control IVD single-useOptical laboratory instrument performance standard calibrator/control IVD single-useClass A
Buffered wash solution IVDBuffered wash solution IVDClass A
Laboratory analyser cuvette IVD single-useLaboratory analyser cuvette IVD single-useClass A
Instrument/analyser cleaning agent IVDInstrument/analyser cleaning agent IVDClass A
Multiplex analyser IVD laboratoryMultiplex analyser IVD laboratoryClass A
Multiplex analyser IVD laboratoryMultiplex analyser IVD laboratoryClass A
Multiplex analyser IVD laboratoryMultiplex analyser IVD laboratoryClass A
Multiplex analyser IVD laboratoryMultiplex analyser IVD laboratoryClass A