INOVA DIAGNOSTICS, INC.

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

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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) Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (2) Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control (MLE) (1) Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) (NHX) (1) System, Test, Anticardiolipin Immunological (MID) (1) System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) (MSV) (1) Extractable Antinuclear Antibody, Antigen And Control (LLL) (1) Autoantibodies, Endomysial(Tissue Transglutaminase) (MVM) (1)

Premarket Exempt

No Yes

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QUANTA Lite® MPO IgG ELISA - 08426950448280 Catalog Number :

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

Prescription Use : Yes

Device Count : 1

QUANTA Lite® PR-3 IgG ELISA - 08426950448303 Catalog Number :

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

Prescription Use : Yes

Device Count : 1

QUANTA Lite® GPA ELISA - 08426950448310 Catalog Number :

Device Description : (Gastric Parietal Cell Antibody) 1.1x GPA ELISA microwell plate (12-1 x 8 wells) (Gastric Parietal Cell Antibody) 1.1x GPA ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted GPA ELISA Low Positive4.1x 1.2mL prediluted GPA ELISA High Positive5.1x 50mL HRP Sample Diluent 6.1x 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 : MLE

Prescription Use : Yes

Device Count : 1

QUANTA Lite® Gliadin IgG II ELISA - 08426950448327 Catalog Number :

Device Description : 1. 1x Gliadin IgG II ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1. 1. 1x Gliadin IgG II ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Gliadin IgG II ELISA Low Positive4. 1x 1.2mL prediluted Gliadin IgG II 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® Gliadin IgA II ELISA - 08426950448334 Catalog Number :

Device Description : 1. 1x Gliadin IgA II ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1. 1. 1x Gliadin IgA II ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Gliadin IgA II ELISA Low Positive4. 1x.2mL prediluted Gliadin IgA II ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA8. 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 : No

Device Count : 1

QUANTA Lite® CCP3 IgG ELISA - 08426950448358 Catalog Number :

Device Description : 1. 1x CCP3 IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pr 1. 1x CCP3 IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted CCP3 IgG ELISA Low Positive4. 1x 1.2mL prediluted CCP3 IgG ELISA High Positive/Calibrator A5. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator B6. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator C7. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator D8. 1x 1.2mL prediluted CCP3 IgG ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP CCP3 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 : NHX

Prescription Use : Yes

Device Count : 1

QUANTA Lite® ACA IgA III - 08426950448389 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 IgA III Control4. 1x 1.2mL prediluted ACA IgA III Calibrator A5. 1x 1.2mL prediluted ACA IgA III Calibrator B6. 1x 1.2mL prediluted ACA IgA III Calibrator C7. 1x 1.2mL prediluted ACA IgA III Calibrator D8. 1x 1.2mL prediluted ACA IgA III Calibrator E9. 1x 50mL ACA III Sample Diluent10. 1x 50mL ACA III PBS Concentrate, 20x concentrate11. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 1x 10mL TMB Chromogen13. 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® β2GPI IgG ELISA - 08426950451112 Catalog Number :

Device Description : 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgG ELISA Control4. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL 2 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 : MSV

Prescription Use : Yes

Device Count : 1

QUANTA Lite® ANA ELISA - 08426950454373 Catalog Number :

Device Description : 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predilu 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ANA ELISA Low Positive4. 1x 1.2mL prediluted ANA ELISA High Positive5. 1x 50mL ANA 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 : LLL

Prescription Use : Yes

Device Count : 1

QUANTA Lite® h-tTG IgA ELISA - 08426950454380 Catalog Number :

Device Description : (Human Tissue Transglutaminase) 1. 1x h-tTG IgA ELISA microwell plate (12-1 x 8 (Human Tissue Transglutaminase) 1. 1x h-tTG IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted h-tTG IgA ELISA Low Positive4. 1x 1.2mL prediluted h-tTG IgA ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MVM

Prescription Use : Yes

Device Count : 1

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