ADVIA Centaur® Systems Calibrator 30

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: ADVIA Centaur® Systems Calibrator 30 FDA UDI
Generic Name: Multiple steroid hormone IVD, calibrator FDA UDI
Device Name: Estradiol - CENTAUR - CAL - 6x2x2mL FDA UDI
Model / Reference: 10379811 FDA UDI
Description: Estradiol - CENTAUR - CAL - 6x2x2mL FDA UDI

Identifiers

Catalog Number: 10379811 FDA UDI
Primary DI / UDI-DI: 00630414578491 FDA UDI
510(k) Number: K100293 FDA UDI
FDA Product Code: JIT FDA UDI
GMDN Term: Multiple steroid hormone 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple steroid hormone IVD, calibrator

The ADVIA Centaur Systems Calibrator 30 is a comprehensive and accurate estradiol - CENTAUR - CAL - 6x2x2mL calibrator, designed for clinical chemistry laboratories to ensure precise measurement of hormone levels in patient samples. With its advanced features and reliable performance, this device helps healthcare professionals make informed decisions about treatment and patient care.

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Also classified as Multiple steroid hormone IVD, calibrator.

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Atellica IM Calibrator 30 — Siemens Healthcare Diagnostics · Class II
ADVIA Centaur® Systems Calibrator 30 — Siemens Healthcare Diagnostics · Class II
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Atellica IM Calibrator 30 — Siemens Healthcare Diagnostics · Class II

Cleared under the same submission

K100293 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI f028749c-5319-4528-9c4a-31524335f373 37 fields · synced Jul 13, 2026