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Dimension® IBCT Calibrator

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® IBCT Calibrator FDA UDI
Generic Name
Total iron binding capacity (TIBC) IVD, calibrator FDA UDI
Device Name
IBCT (Total Iron Binding Protein) Calibrator, 2x3x1mL FDA UDI
Model / Reference
10445006 FDA UDI
Description
IBCT (Total Iron Binding Protein) Calibrator, 2x3x1mL FDA UDI

Identifiers

Catalog Number
DC84 FDA UDI
Primary DI / UDI-DI
00842768005206 FDA UDI
510(k) Number
K994114 FDA UDI
FDA Product Code
JIS FDA UDI
GMDN Term
Total iron binding capacity (TIBC) IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 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

Yes

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: Total iron binding capacity (TIBC) IVD, calibrator

Dimension® IBCT Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total iron binding capacity (TIBC) IVD, calibrator.

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 4c85b0c5-6edb-4cc8-988c-bf8b912c94c2 37 fields · synced May 30, 2026