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EliA IgA Curve Control

FDA UDI

Class II (US FDA UDI)

by Phadia GmbH

Identity

Trade Name
EliA IgA Curve Control FDA UDI
Generic Name
Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
EliA IgA Curve Control FDA UDI
Model / Reference
83-0002-71 FDA UDI
Description
EliA IgA Curve Control FDA UDI

Identifiers

Catalog Number
83-0002-71 FDA UDI
Primary DI / UDI-DI
07333066012773 FDA UDI
510(k) Number
K062787 FDA UDI
FDA Product Code
MVM FDA UDI
GMDN Term
Total immunoglobulin A (IgA total) 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

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: Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA)

EliA IgA Curve Control by Phadia GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K062787 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phadia GmbH

Sources (1)

  • FDA UDI ee068ba0-e4ed-442e-a7fa-c05ab1a27f47 37 fields · synced Jun 8, 2026