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Fidis

FDA UDI

by Theradiag Sa

Identity

Trade Name
FIDIS FDA UDI
Generic Name
Multiple vasculitis-associated antibody IVD, kit, multiplex FDA UDI
Device Name
Simultaneous detection kit of anti-myeloperoxidase, anti-proteinase 3 and anti-glomerular basement membrane antibodies. FDA UDI
Model / Reference
Vasculitis FDA UDI
Description
Simultaneous detection kit of anti-myeloperoxidase, anti-proteinase 3 and anti-glomerular basement membrane antibodies. FDA UDI

Identifiers

Catalog Number
MX 507 FDA UDI
Primary DI / UDI-DI
03760170782010 FDA UDI
GMDN Term
Multiple vasculitis-associated antibody IVD, kit, multiplex FDA UDI

Classification

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: Multiple vasculitis-associated antibody IVD, kit, multiplex

Fidis by Theradiag Sa — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple vasculitis-associated antibody IVD, kit, multiplex.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Theradiag Sa

Sources (1)

  • FDA UDI 119b613d-a07b-4071-8bb0-9c44e709b20e 36 fields · synced May 30, 2026