← Back to catalogue

DRI T-Uptake (EIA Assay)

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 0723

by Microgenics Corporation

Identity

Trade Name
DRI T-Uptake FDA UDI
Generic Name
Multiple thyroid hormone uptake (T-uptake) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
DRI T-Uptake (EIA Assay) EUDAMED
Model / Reference
0723 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00884883003453 EUDAMEDFDA UDI
Basic UDI-DI
B-00884883003453 EUDAMED
FDA Product Code
KHQ FDA UDI
EMDN Code
W0102090299 TOXICOLOGY - OTHER EUDAMED
GMDN Term
Multiple thyroid hormone uptake (T-uptake) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
862.1715 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

DRI T-Uptake (EIA Assay) 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Microgenics Corporation
EUDAMED SRN
US-MF-000030375
Authorised Representative
B·R·A·H·M·S GmbH DE-AR-000026031

Sources (2)

  • EUDAMED f487feae-af59-4907-989d-c884b533c73f 61 fields · synced Jun 18, 2026
  • FDA UDI c51a818e-1805-469a-9886-c88b5d2de11f 32 fields · synced May 30, 2026