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DRI Cotinine Calibrator Kit

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 0404

by Microgenics Corporation

Identity

Trade Name
DRI Cotinine Calibrator Kit FDA UDI
Generic Name
Cotinine (nicotine metabolite) IVD, calibrator FDA UDI
Device Name
DRI Cotinine Calibrator Kit EUDAMED
Model / Reference
0404 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00884883001060 EUDAMEDFDA UDI
Basic UDI-DI
B-00884883001060 EUDAMED
FDA Product Code
MKU FDA UDI
EMDN Code
W0102090108 COTININE EUDAMED
GMDN Term
Cotinine (nicotine metabolite) IVD, calibrator FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
862.3220 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

Yes

EUDAMED

Animal Tissues

Yes

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

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 Cotinine Calibrator Kit 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 032127af-2d77-4ec5-8da6-67845f62e16a 61 fields · synced Aug 2, 2026
  • FDA UDI 55e2c689-d064-447e-90e2-e8a3834428a4 32 fields · synced May 30, 2026