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QMedix™

FDA UDI

Class I (US FDA UDI)

by Diagnostic Automation, Inc.

Identity

Trade Name
QMedix™ FDA UDI
Generic Name
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
QMedix™ EBV VCA IgG ImmunoFlourescent Assay FDA UDI
Model / Reference
DACD401010-G FDA UDI
Description
QMedix™ EBV VCA IgG ImmunoFlourescent Assay FDA UDI

Identifiers

Catalog Number
401010-G FDA UDI
Primary DI / UDI-DI
00850054026613 FDA UDI
FDA Product Code
MCD FDA UDI
GMDN Term
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3235 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

No

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: Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

QMedix™ by Diagnostic Automation, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostic Automation, Inc.

Sources (1)

  • FDA UDI 14a9394e-18f2-4881-a9b6-96c9c1604dbc 37 fields · synced May 29, 2026