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

Extractable Antinuclear Antibody, Antigen And Control (LLL) (4) Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) (MVJ) (1) Antibodies, Gliadin (MST) (1) System, Test, Anticardiolipin Immunological (MID) (1) System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) (MSV) (1) Thyroglobulin, Antigen, Antiserum, Control (DDC) (1) Radioassay, Intrinsic Factor Blocking Antibody (LIG) (1)

Premarket Exempt

No Yes

Clear

QUANTA Lite® TPO ELISA - 08426950454458 Catalog Number :

Device Description : 1. 1x TPO ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predilu 1. 1x TPO ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted TPO ELISA Control4. 1x 1.2mL prediluted TPO ELISA Calibrator A5. 1x 1.2mL prediluted TPO ELISA Calibrator B6. 1x 1.2mL prediluted TPO ELISA Calibrator C7. 1x 1.2mL prediluted TPO ELISA Calibrator D8. 1x 1.2mL prediluted TPO ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG12. 1x 10mL TMB Chromogen13. 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

QUANTA Lite® Thyroid T ELISA - 08426950454465 Catalog Number :

Device Description : 1. 1x Thyroid T ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL p 1. 1x Thyroid T ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Thyroid T ELISA Low Positive4. 1x 1.2mL prediluted Thyroid T ELISA High Positive (Calibrator A)5. 1x 1.2mL prediluted Thyroid T ELISA Calibrator B6. 1x 1.2mL prediluted Thyroid T ELISA Calibrator C7. 1x 1.2mL prediluted Thyroid T ELISA Calibrator D8. 1x 1.2mL prediluted Thyroid T ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : DDC

Prescription Use : Yes

Device Count : 1

QUANTA Lite® β2GPI Screening ELISA - 08426950454472 Catalog Number :

Device Description : 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2 GPI Decision Point4. 1x 1.2mL prediluted β2 GPI Screening Control5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MSV

Prescription Use : Yes

Device Count : 1

QUANTA Lite® ACA Screen III - 08426950454489 Catalog Number :

Device Description : 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA III Decision Point4. 1x 1.2mL prediluted ACA III Screen Control5. 1x 50mL ACA III Sample Diluent6. 1x 50mL ACA III PBS Concentrate, 20x concentrate7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human IgGAM8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MID

Prescription Use : Yes

Device Count : 1

QUANTA Lite® ENA 4 ELISA - 08426950454496 Catalog Number :

Device Description : 1. 1x ENA 4 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predi 1. 1x ENA 4 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ENA 4 ELISA Low Positive4. 1x 1.2mL prediluted ENA 4 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

QUANTA Lite® dsDNA ELISA - 08426950454502 Catalog Number :

Device Description : 1. 1x dsDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x1.2mL predi 1. 1x dsDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted dsDNA ELISA Positive4. 1x 1.2mL prediluted dsDNA ELISA Calibrator5. 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

QUANTA Lite® Gliadin IgG ELISA - 08426950454519 Catalog Number :

Device Description : 1 .1x Gliadin IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL 1 .1x Gliadin IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Gliadin IgG ELISA Low Positive4. 1x 1.2mL prediluted Gliadin IgG 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 : MST

Prescription Use : Yes

Device Count : 1

QUANTA Lite® Intrinsic Factor ELISA - 08426950454526 Catalog Number :

Device Description : 1.1x Intrinsic Factor ELISA microwell plate, (12-1 x 8 wells), with holder2.1x 1 1.1x Intrinsic Factor ELISA microwell plate, (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3.1x1.2mL prediluted Intrinsic Factor ELISA Low Positive4.1x 1.2mL prediluted Intrinsic Factor ELISA High Positive5.1x 50mL HRP Sample Diluent6.1x 25mL HRP Wash Concentrate, 40x concentrate7.1x 10mL HRP IgG Conjugate, (goat) 8.1x 10mL TMB Chromogen9.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : LIG

Prescription Use : Yes

Device Count : 1

QUANTA Lite® GBM ELISA - 08426950454533 Catalog Number :

Device Description : 1. 1x GBM ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predil 1. 1x GBM ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted GBM ELISA Low Positive4. 1x 1.2mL prediluted GBM ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HS 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 : MVJ

Prescription Use : Yes

Device Count : 1

QUANTA Lite® ENA 6 ELISA - 08426950455127 Catalog Number :

Device Description : 1. 1x ENA 6 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predi 1. 1x ENA 6 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ENA 6 ELISA Low Positive4. 1x 1.2mL prediluted ENA 6 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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