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ADVIA Centaur® DIG MCM

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA Centaur® DIG MCM FDA UDI
Generic Name
Digoxin therapeutic drug monitoring IVD, control FDA UDI
Device Name
Digoxin Master Curve Material - CENTAUR - CONS FDA UDI
Model / Reference
10311623 FDA UDI
Description
Digoxin Master Curve Material - CENTAUR - CONS FDA UDI

Identifiers

Catalog Number
672426000 FDA UDI
Primary DI / UDI-DI
00630414126296 FDA UDI
510(k) Number
K140267 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Digoxin therapeutic drug monitoring IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Digoxin therapeutic drug monitoring IVD, control

ADVIA Centaur® DIG MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Digoxin therapeutic drug monitoring IVD, control.

Cleared under the same submission

K140267 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI acc6170f-7672-47c4-a594-5bb89bf5f6f5 37 fields · synced May 30, 2026