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Immuno-Trol

FDA UDI

by Theradiag Sa

Identity

Trade Name
IMMUNO-TROL FDA UDI
Generic Name
Multiple vasculitis-associated antibody IVD, control FDA UDI
Device Name
Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti- Myeloperoxidase MPO , anti- Proteinase 3 PR3 , anti-Glomerular Basal Membrane GBM . FDA UDI
Model / Reference
VASCULITIS FDA UDI
Description
Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti- Myeloperoxidase MPO , anti- Proteinase 3 PR3 , anti-Glomerular Basal Membrane GBM . FDA UDI

Identifiers

Catalog Number
HM 067US-2X05 FDA UDI
Primary DI / UDI-DI
03760170782096 FDA UDI
GMDN Term
Multiple vasculitis-associated antibody IVD, control 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

Yes

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, control

Immuno-Trol by Theradiag Sa — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple vasculitis-associated antibody IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Theradiag Sa

Sources (1)

  • FDA UDI dc8cab59-6155-42c6-a377-f2d520364916 36 fields · synced May 30, 2026