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) (6) Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) (NHX) (1) Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (DHN) (1) Autoantibodies, Endomysial(Tissue Transglutaminase) (MVM) (1) Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (1)

Premarket Exempt

No Yes

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NOVA Lite® dsDNA Crithidia Luciliae - 08426950455882 Catalog Number :

Device Description : 1. 10x 6-well dsDNA Crithidia luciliae Substrate Slides2. 1x 4mL FITC Anti Human 1. 10x 6-well dsDNA Crithidia luciliae Substrate Slides2. 1x 4mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL dsDNA Positive4. 1x 0.5mL IFA System Negative Control5. 1x 25mL PBS II Concentrate (40x)6. 1x 7mL Mounting Medium7. 1x 10 Coverslips

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : DHN

Prescription Use : Yes

Device Count : 1

QUANTA Lite® CCP3.1 IgG/IgA ELISA - 08426950456124 Catalog Number :

Device Description : 1. 1x CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1. 1. 1x CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Low Positive4. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA High Positive/Calibrator A5. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator B6. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator C7. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator D8. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 100mL High Specificity Wash Concentrate, 10x concentrate11. 1x 10mL HRP CCP3.1 IgG/IgA Conjugate, (goat), anti-human IgG/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 : NHX

Prescription Use : Yes

Device Count : 1

QUANTA Lite® h-tTG IgG ELISA - 08426950456131 Catalog Number :

Device Description : (Human Tissue Transglutaminase)1. 1x ANA ELISA microwell plate (12-1 x 8 wells), (Human Tissue Transglutaminase)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 : MVM

Prescription Use : Yes

Device Count : 1

QUANTA Lite® Sm ELISA - 08426950456148 Catalog Number :

Device Description : 1. 1 x Sm ELISA microwell plate (12-1 x 8 wells), with holder2. 1 x 1.2mL predi 1. 1 x Sm ELISA microwell plate (12-1 x 8 wells), with holder2. 1 x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Sm ELISA Low Positive4. 1x 1.2mL prediluted Sm 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. 1 x10mL 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® RNP ELISA - 08426950456155 Catalog Number :

Device Description : 1. 1 x RNP ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predi 1. 1 x RNP ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted RNP ELISA Low Positive4. 1x 1.2mL prediluted RNP ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1 x 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® SS-A ELISA - 08426950456162 Catalog Number :

Device Description : 1. 1x SS-A ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predil 1. 1x SS-A ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted SS-A ELISA Low Positive4. 1x 1.2mL prediluted SS-A 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® SS-B ELISA - 08426950456179 Catalog Number :

Device Description : 1. 1x SS-B ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predil 1. 1x SS-B ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted SS-B ELISA Low Positive4. 1x 1.2mL prediluted SS-B 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® Scl-70 ELISA - 08426950456186 Catalog Number :

Device Description : 1. 1x Scl-70 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x Scl-70 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Scl-70 ELISA Low Positive4. 1x 1.2mL prediluted Scl-70 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 : LLL

Prescription Use : Yes

Device Count : 1

NOVA Lite® HEp-2 ANA Kit - 08426950456193 Catalog Number :

Device Description : 1. 20x Hep- 2 ANA Slide (12 well)2. 1x 0.5mL IFA System Negative Control3. 1x 1. 20x Hep- 2 ANA Slide (12 well)2. 1x 0.5mL IFA System Negative Control3. 1x 15mL FITC IgG Conjugate 4. 1x 7mL Mounting Medium5. 2x 25mL PBS II Concentrate (40x)6 .1x Coverlips, 20 each7. 1x 0.5mL ANA Titratable Pattern

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : LLL

Prescription Use : Yes

Device Count : 1

NOVA Lite® ANCA Kit - 08426950456216 Catalog Number :

Device Description : 1. 10x 6-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 4mL FITC 1. 10x 6-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 4mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 1x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 10 Coverslips

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MOB

Prescription Use : Yes

Device Count : 1

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