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EliA Gliadin IgG Well

FDA UDIEUDAMED

Class II (US FDA UDI)

by Phadia GmbH

Identity

Trade Name
EliA Gliadin IgG Well FDA UDI
Generic Name
Gliadin antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
EliA Gliadin IgG Well FDA UDI
Model / Reference
DECC055200 FDA UDI
Description
EliA Gliadin IgG Well FDA UDI

Identifiers

Catalog Number
DECC055200 FDA UDI
Primary DI / UDI-DI
07333066014692 FDA UDI
510(k) Number
K063775 FDA UDI
FDA Product Code
MST FDA UDI
GMDN Term
Gliadin antibody IVD, kit, fluorescent immunoassay 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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, fluorescent immunoassay

EliA Gliadin IgG Well by Phadia GmbH — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Gliadin antibody IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K063775 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phadia GmbH

Sources (2)

  • FDA UDI bb455d8e-c03d-42f9-8f62-e4b694409686 37 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced May 22, 2026