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DRI Thyroxine (T4)

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 10013070

by Microgenics Corporation

Identity

Trade Name
DRI Thyroxine (T4) FDA UDI
Generic Name
Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
DRI Thyroxine (T4) EUDAMED
Model / Reference
10013070 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00884883004177 EUDAMEDFDA UDI
Basic UDI-DI
B-00884883004177 EUDAMED
510(k) Number
K944703 FDA UDI
FDA Product Code
KLI FDA UDI
EMDN Code
W01020407 THYROXINE EUDAMED
GMDN Term
Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
862.1700 FDA UDI
Market of Registration
Germany 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

Yes

EUDAMED

Microbial Substances

Yes

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

New Device

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

DRI Thyroxine (T4) by Microgenics Corporation — 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
Microgenics Corporation
EUDAMED SRN
US-MF-000030375
Authorised Representative
B·R·A·H·M·S GmbH DE-AR-000026031

Sources (2)

  • EUDAMED 62dbe41a-45fc-4500-97cc-2bf4e7191900 61 fields · synced Jul 13, 2026
  • FDA UDI 77dda4a7-ebfc-49ff-81e8-d48a5a1e7e48 33 fields · synced May 30, 2026