← Back to catalogue

QUANTA Lite® MPO SC ELISA

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name
QUANTA Lite® MPO SC ELISA FDA UDI
Generic Name
Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-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. MPO SC Coated Wells: 12 breakapart 8 well strips coated with MPO antigen, colour coded green. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches. 4. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured yellow, ready to use. 5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. MPO SC ELISA Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-MPO autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use. 7. MPO SC Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use. 8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 9. HRP MPO SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured blue, ready to use. 10.TMB Chromogen: 1 bottle containing 10mL TMB substrate. Ready to use. 11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric acid. Ready to use. FDA UDI
Model / Reference
704655 FDA UDI
Description
1. Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. MPO SC Coated Wells: 12 breakapart 8 well strips coated with MPO antigen, colour coded green. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches. 4. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured yellow, ready to use. 5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. MPO SC ELISA Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-MPO autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use. 7. MPO SC Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use. 8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use. 9. HRP MPO SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured blue, ready to use. 10.TMB Chromogen: 1 bottle containing 10mL TMB substrate. Ready to use. 11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric acid. Ready to use. FDA UDI

Identifiers

Primary DI / UDI-DI
08426950544180 FDA UDI
510(k) Number
K981030 FDA UDI
FDA Product Code
MOB FDA UDI
GMDN Term
Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-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: Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K981030 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (1)

  • FDA UDI 67aeb4de-3c6a-4d7f-b0e6-c25a090239e5 36 fields · synced May 30, 2026