QUANTA Lite® Gliadin IgA II ELISA

FDA UDI

Class II (US FDA UDI)

by Inova Diagnostics, Inc.

Identity

Trade Name: QUANTA Lite® Gliadin IgA II ELISA FDA UDI
Generic Name: Gliadin antibody IVD, calibrator FDA UDI
Device Name: 1. 1x Gliadin IgA II ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Gliadin IgA II ELISA Low Positive 4. 1x.2mL prediluted Gliadin IgA II ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Model / Reference: 704525 FDA UDI
Description: 1. 1x Gliadin IgA II ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Gliadin IgA II ELISA Low Positive 4. 1x.2mL prediluted Gliadin IgA II ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI

Identifiers

Primary DI / UDI-DI: 08426950448334 FDA UDI
510(k) Number: K052143 FDA UDI
FDA Product Code: MST FDA UDI
GMDN Term: Gliadin antibody IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Gliadin antibody IVD, kit, enzyme immunoassay (EIA)Gliadin antibody IVD, calibrator

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

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Cleared under the same submission

K052143 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Inova Diagnostics, Inc.

Sources (1)

FDA UDI d1de1707-c3af-4b42-a0da-2a816eaa1e58 36 fields · synced Jun 6, 2026