Identity
- Trade Name
- QUANTA Lite® Celiac DGP Screen ELISA FDA UDI
- Generic Name
- Gliadin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. 1x Celiac DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Celiac DGP Screen ELISA Low Positive 4. 1x 1.2mL prediluted Celiac DGP Screen ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP Ig G/A Conjugate, (goat), anti-human IgG and IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
- Model / Reference
- 704545 FDA UDI
- Description
- 1. 1x Celiac DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Celiac DGP Screen ELISA Low Positive 4. 1x 1.2mL prediluted Celiac DGP Screen ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP Ig G/A Conjugate, (goat), anti-human IgG and IgA 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950593324 FDA UDI
- 510(k) Number
- K062708 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® Celiac DGP Screen ELISA by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gliadin antibody IVD, kit, enzyme immunoassay (EIA).
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- a-Gliatest IgG — Eurospital
- a-Gliatest IgA — Eurospital · Class II
- a-GliaPep IgG — Eurospital · Class II
- EL-Glia IgA/IgG — THERATEST LABORATORIES, INC.
- a-GliaPep IgA — Eurospital · Class II
- Anti-Gliadin (GAF-3X) ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI f178d8fc-c9a7-4941-a1e0-80e98227d8b8 36 fields · synced Jun 8, 2026