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,Saccharomyces Cerevisiae (S.Cerevisiae) (NBT) (2) Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (2) Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (DHN) (1) Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control (LRM) (1) Extractable Antinuclear Antibody, Antigen And Control (LLL) (1) Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (DBL) (1) Autoantibodies, Endomysial(Tissue Transglutaminase) (MVM) (1) Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls (LJM) (1)

Premarket Exempt

No Yes

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NOVA Lite® ANCA Kit - 08426950512912 Catalog Number :

Device Description : 1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 15mL FI 1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 15mL 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. 2x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 20 Coverslips

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MOB

Prescription Use : Yes

Device Count : 1

NOVA Lite® Monkey Oesophagus IFA Kit - 08426950513988 Catalog Number :

Device Description : 1. 10 x Monkey Oesophagus – 5-well slide2. 1 x 1mL Pemphigus Positive Control (p 1. 10 x Monkey Oesophagus – 5-well slide2. 1 x 1mL Pemphigus Positive Control (prediluted)3. 1 x 1mL Endomysial (Celiac) Positive Control (prediluted)4. 1 x 1mL IFA System Negative Control (prediluted)5. 1 x 7mL FITC IgG (H&L), monkey adsorbed Conjugate6. 1 x 7mL Anti-Human IgA (α) AFF FITC7. 1 x 3mL 1% Evans Blue Counterstain8. 2 x 25mL PBS II concentrate (x40)9. 1 x 3mL Mounting Medium10. 10 x Coverslips 11. 1 x instruction leaflet

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MVM

Prescription Use : Yes

Device Count : 1

NOVA Lite® ANCA Kit - 08426950513995 Catalog Number :

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : MOB

Prescription Use : Yes

Device Count : 1

NOVA Lite® ANA KSL Kit - 08426950514008 Catalog Number :

Device Description : 1. 25x 8-well ANA KSL Substrate Slides2. 1x 15mL FITC Anti-Human IgG Conjugate3. 1. 25x 8-well ANA KSL Substrate Slides2. 1x 15mL FITC Anti-Human IgG Conjugate3. 1x 1.0mL ANA Homogeneous Pattern4. 1x 1.0mL IFA System Negative Control5. 2x 25mL PBS Concentrate (40x)6. 1x 10mL Mounting Medium7. 1x 25 Coverslips

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : DHN

Prescription Use : Yes

Device Count : 1

QUANTA Lite® Jo-1 ELISA - 08426950514015 Catalog Number :

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

NOVA Lite®Rat Liver , Kidney, Stomach Kit - 08426950514176 Catalog Number :

Device Description : 1. 10 x Rat liver, kidney, stomach slide (5-well)2. 1 x 1mL ANA Homogeneous Patt 1. 10 x Rat liver, kidney, stomach slide (5-well)2. 1 x 1mL ANA Homogeneous Pattern (prediluted)3. 1 x 1mL IFA System Negative Control (prediluted)4. 1 x 1mL Mitochondrial (AMA) Pattern (prediluted) 5. 1 x 1mL Smooth Muscle (ASMA) Pattern (prediluted) 6. 1 x 7mL FITC IgG (H&L) Conjugate 7. 1 x 3mL 1% Evans Blue Counterstain8. 2 x 25mL PBS II Buffer (x40 conc)9. 1 x 3mL Mounting Medium10. 20 x Blotters11. 10 x Coverslips 12. 1 x instruction leaflet

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : DBL

Prescription Use : Yes

Device Count : 1

QUANTA Lite® ASCA IgG ELISA - 08426950514206 Catalog Number :

Device Description : (S. cerevisiae)1. 1x ASCA IgG ELISA microwell plate (12-1 x 8 wells), with holde (S. cerevisiae)1. 1x ASCA IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ASCA IgG ELISA Low Positive4. 1x 1.2mL prediluted ASCA IgG 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 : NBT

Prescription Use : Yes

Device Count : 1

QUANTA Lite® ASCA IgA ELISA - 08426950514213 Catalog Number :

Device Description : (S. cerevisiae)1. 1x ASCA IgA ELISA microwell plate (12-1 x 8 wells), with holde (S. cerevisiae)1. 1x ASCA IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ASCA IgA ELISA Low Positive4. 1x 1.2mL prediluted ASCA 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. 1x10mL HRP Stop Solution, 0.344M Sulfuric Acid

Device Class : 2

Duns Number: 188354831

Premarket Exempt : No

Product Code : NBT

Prescription Use : Yes

Device Count : 1

QUANTA Lite® dsDNA SC ELISA - 08426950544111 Catalog Number :

Device Description : 1.Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating t 1.Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. dsDNA SC Coated Wells: 12 breakapart 8 well strips coated with calf thymus dsDNA antigen. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.5. dsDNA SC Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-dsDNA autoantibody: 1000, 333, 111, 37, 12.3 IU/mL. Ready to use.6. dsDNA SC Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use.8. HRP Wash Concentrate (40X): 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.9.dsDNA SC Single Stranded Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.10. HRP dsDNA SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.11. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.12. 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 : LRM

Prescription Use : Yes

Device Count : 1

QUANTA Lite® Centromere ELISA - 08426950544128 Catalog Number :

Device Description : (CENP-A & CENP-B)1.1x Centromere ELISA microwell plate (12-1 x 8 wells), with ho (CENP-A & CENP-B)1.1x Centromere ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted Centromere ELISA Low Positive4.1x 1.2mL prediluted Centromere ELISA High Positive5.1x 50mL HRP Sample Diluent6.1 x25mL 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 : LJM

Prescription Use : Yes

Device Count : 1

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