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QUANTA LITE® Gliadin IgG II ELISA Bulk Pack (Lab Corp)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- QUANTA LITE® Gliadin IgG II ELISA Bulk Pack (Lab Corp) FDA UDI
- Generic Name
- Gliadin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. 10x Gliadin IgG II ELISA Plate 2. 5x 1.2mL Gliadin IgG II ELISA Low Positive 3. 5x 1.2mL Gliadin IgG II ELISA High Positive 4. 10x 10mL HRP IgG Conjugate 5. 10x 10mL TMB Chromogen 6. 10x 10mL HRP Stop Solution 7. 9 x50mL HRP Sample Diluent 8. 10x 25mL HRP Wash Concentrate, 40x concentrate 9. 5x 1.2mL ELISA Negative Control FDA UDI
- Model / Reference
- 704520.10L FDA UDI
- Description
- 1. 10x Gliadin IgG II ELISA Plate 2. 5x 1.2mL Gliadin IgG II ELISA Low Positive 3. 5x 1.2mL Gliadin IgG II ELISA High Positive 4. 10x 10mL HRP IgG Conjugate 5. 10x 10mL TMB Chromogen 6. 10x 10mL HRP Stop Solution 7. 9 x50mL HRP Sample Diluent 8. 10x 25mL HRP Wash Concentrate, 40x concentrate 9. 5x 1.2mL ELISA Negative Control FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950594024 FDA UDI
- 510(k) Number
- K052142 FDA UDI
- FDA Product Code
- MST FDA UDI
- GMDN Term
- Gliadin antibody IVD, kit, enzyme immunoassay (EIA) 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
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: Gliadin antibody IVD, kit, enzyme immunoassay (EIA)
QUANTA LITE® Gliadin IgG II ELISA Bulk Pack (Lab Corp) by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gliadin antibody IVD, kit, enzyme immunoassay (EIA).
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Cleared under the same submission
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 91d18935-d740-4770-8edf-1d5f3a0c7e46 36 fields · synced May 30, 2026