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Triiodothyronine (T3) ELISA

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref CAN-T3-4220Model 96 Tests

by Diagnostics Biochem Canada Inc.

Identity

Trade Name
NA FDA UDI
Generic Name
Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Triiodothyronine (T3) ELISA EUDAMED
TRIIODOTHYRONINE (T3) ELISA KIT FOR THE QUANTITATIVE MEASUREMENT OF TRIIODOTHYRONINE IN HUMAN SERUM FDA UDI
Model / Reference
96 Tests EUDAMED
CAN-T3-4220 EUDAMEDFDA UDI
Description
TRIIODOTHYRONINE (T3) ELISA KIT FOR THE QUANTITATIVE MEASUREMENT OF TRIIODOTHYRONINE IN HUMAN SERUM FDA UDI

Identifiers

Catalog Number
CAN-T3-4220 FDA UDI
Primary DI / UDI-DI
++B261CANT34220F3 EUDAMED
B261CANT342200 FDA UDI
Basic UDI-DI
B-++B261CANT34220F3 EUDAMED
FDA Product Code
CDP FDA UDI
EMDN Code
W01020405 TRIIODOTHYRONINE EUDAMED
GMDN Term
Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
862.1710 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Triiodothyronine (T3) ELISA by Diagnostics Biochem Canada Inc — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostics Biochem Canada Inc.
EUDAMED SRN
CA-MF-000032449
Authorised Representative
MedEnvoy Global BV NL-AR-000024028

Sources (2)

  • EUDAMED ed89e1e0-008a-4ae2-b995-8b0b7005e99c 61 fields · synced Jul 14, 2026
  • FDA UDI c9d9f869-2664-4557-a716-c44e2d0b4ff8 36 fields · synced May 30, 2026