INOVA DIAGNOSTICS, INC.

Address:9900 Old Grove Rd,SAN DIEGO,CA,92131,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Antibodies, Gliadin (MST) (2) Autoantibodies, Endomysial(Tissue Transglutaminase) (MVM) (2) System, Test, Anticardiolipin Immunological (MID) (2) Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (2) Anti-Ss-A 52 Autoantibodies (OBE) (1) Extractable Antinuclear Antibody, Antigen And Control (LLL) (1)

Premarket Exempt

No Yes

Clear

QUANTA Lite® SS-A 52 ELISA - 08426950544135 Catalog Number :

Device Description : 1. 1x SS-A 52 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pre 1. 1x SS-A 52 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ready to use ELISA Negative Control 3. 1x 1.2mL prediluted ready to use SS-A 52 ELISA Low Positive4. 1x 1.2mL prediluted ready to use SS-A 52 ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : OBE

Prescription Use : Yes

Device Count : 1

QUANTA Lite® R h-tTG IgG ELISA - 08426950544142 Catalog Number :

Device Description : 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use.5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.6. R h-tTG IgG Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgG autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7. R h-tTG IgG Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP R h-tTG IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.11. Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MVM

Prescription Use : Yes

Device Count : 1

QUANTA Flash® h-tTG IgG Reagents - 08426950544159 Catalog Number :

Device Description : 1. 1 QUANTA Flash h-tTG IgG reagent cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MVM

Prescription Use : Yes

Device Count : 1

QUANTA Flash® DGP IgG Reagents - 08426950544166 Catalog Number :

Device Description : 1. 1 QUANTA Flash DGP IgG Reagent Cartridge

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MST

Prescription Use : Yes

Device Count : 1

QUANTA Flash® DGP IgA Reagents - 08426950544173 Catalog Number :

Device Description : 1. 1 QUANTA Flash DGP IgA Reagent Cartridge

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MST

Prescription Use : Yes

Device Count : 1

QUANTA Lite® MPO SC ELISA - 08426950544180 Catalog Number :

Device Description : 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. MPO SC Coated Wells: 12 breakapart 8 well strips coated with MPO antigen, colour coded green. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured yellow, ready to use.5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. MPO SC ELISA Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-MPO autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7. MPO SC Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP MPO SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured blue, ready to use.10.TMB Chromogen: 1 bottle containing 10mL TMB substrate. Ready to use.11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric acid. Ready to use.

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MOB

Prescription Use : Yes

Device Count : 1

QUANTA Flash® MPO Reagents - 08426950544197 Catalog Number :

Device Description : 1. 1 QUANTA Flash MPO Reagent Cartridge

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MOB

Prescription Use : Yes

Device Count : 1

QUANTA Flash® aCL IgG Reagents - 08426950544203 Catalog Number :

Device Description : 1. 1 QUANTA Flash aCL IgG Reagent Cartridge2. 1 QUANTA Flash aCL IgG Calibrator 1. 1 QUANTA Flash aCL IgG Reagent Cartridge2. 1 QUANTA Flash aCL IgG Calibrator 1 3. 1 QUANTA Flash aCL IgG Calibrator 2

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MID

Prescription Use : Yes

Device Count : 1

QUANTA Flash® aCL IgM Reagents - 08426950544210 Catalog Number :

Device Description : 1. 1 QUANTA Flash aCL IgM Reagent Cartridge2. 1 QUANTA Flash aCL IgM Calibrator 1. 1 QUANTA Flash aCL IgM Reagent Cartridge2. 1 QUANTA Flash aCL IgM Calibrator 1 3. 1 QUANTA Flash aCL IgM Calibrator 2

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MID

Prescription Use : Yes

Device Count : 1

QUANTA Lite® ENA 5 ELISA - 08426950544227 Catalog Number :

Device Description : 1. 1x ENA 5 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predi 1. 1x ENA 5 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ENA 5 ELISA Low Positive4. 1x 1.2mL prediluted ENA 5 ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : LLL

Prescription Use : Yes

Device Count : 1

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