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QUANTA Lite® PR3 SC ELISA Bulk Pack

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Lite® PR3 SC ELISA Bulk Pack FDA UDI
Generic Name
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
1 .Instruction leaflet: Giving full assay details. 2.QC Certificate: Indicating the expected performance of the batch. 3. PR3 SC Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with PR3 antigen, colour coded red. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches. 4.Type III Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured yellow, ready to use. 5. HRP Wash Concentrate: 10 bottles containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. PR3 SC ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-PR3 autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use. 7. PR3 SC Positive Control: 5 bottles containing 1.2mL of diluted human serum. Ready to use. 8.ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. Ready to use. 9. HRP PR3 SC IgG Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured blue, ready to use. 10.TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use. 11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use. FDA UDI
Model / Reference
704660.10 FDA UDI
Description
1 .Instruction leaflet: Giving full assay details. 2.QC Certificate: Indicating the expected performance of the batch. 3. PR3 SC Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with PR3 antigen, colour coded red. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches. 4.Type III Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured yellow, ready to use. 5. HRP Wash Concentrate: 10 bottles containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. PR3 SC ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-PR3 autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use. 7. PR3 SC Positive Control: 5 bottles containing 1.2mL of diluted human serum. Ready to use. 8.ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. Ready to use. 9. HRP PR3 SC IgG Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured blue, ready to use. 10.TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use. 11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use. FDA UDI

Identifiers

Primary DI / UDI-DI
08426950594550 FDA UDI
510(k) Number
K981029 FDA UDI
FDA Product Code
MOB FDA UDI
GMDN Term
Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)

QUANTA Lite® PR3 SC ELISA Bulk Pack by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K981029 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (1)

  • FDA UDI cada9924-210f-4322-bbd2-d15d4154db34 36 fields · synced Jun 8, 2026