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EliA IgG Calibrators

FDA UDI

Class II (US FDA UDI)

by Phadia GmbH

Identity

Trade Name
EliA IgG Calibrators FDA UDI
Generic Name
Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Contains one vial of each Calibrator (Cal-0, Cal-4, Cal-10, Cal-20, Cal-100, Cal-600) to form a complete calibration curve for EliA IgG method. FDA UDI
Model / Reference
83-1000-01 FDA UDI
Description
Contains one vial of each Calibrator (Cal-0, Cal-4, Cal-10, Cal-20, Cal-100, Cal-600) to form a complete calibration curve for EliA IgG method. FDA UDI

Identifiers

Catalog Number
83-1000-01 FDA UDI
Primary DI / UDI-DI
07333066020051 FDA UDI
FDA Product Code
NHX FDA UDI
GMDN Term
Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5775 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

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: Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

EliA IgG Calibrators by Phadia GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phadia GmbH

Sources (1)

  • FDA UDI 94a1170d-f36e-439c-9e8a-7cc6b8b9e3b6 36 fields · synced May 30, 2026