← Back to catalogue
ADVIA Centaur® Systems, ACS:180® Systems CAL Calibrator E
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA Centaur® Systems, ACS:180® Systems CAL Calibrator E FDA UDI
- Generic Name
- Multiple steroid hormone IVD, calibrator FDA UDI
- Device Name
- Cortisol (6PK) - CENTAUR - CAL - 6x2x2mL FDA UDI
- Model / Reference
- 10321075 FDA UDI
- Description
- Cortisol (6PK) - CENTAUR - CAL - 6x2x2mL FDA UDI
Identifiers
- Catalog Number
- 4634762 FDA UDI
- Primary DI / UDI-DI
- 00630414524726 FDA UDI
- 510(k) Number
- K932955 FDA UDI
- FDA Product Code
- JIS 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
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: Multiple steroid hormone IVD, calibrator
ADVIA Centaur® Systems, ACS:180® Systems CAL Calibrator E by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Multiple steroid hormone IVD, calibrator.
- Ionify CalSet Steroids and Vitamin D — Roche Diagnostics Corp. · Class II
- Serum Calibrator Set — Chromsystems Instruments & Chemicals GmbH · Class II
- Serum Calibrator Set — Chromsystems Instruments & Chemicals GmbH · Class II
- Serum Calibrator Set — Chromsystems Instruments & Chemicals GmbH · Class II
- Atellica IM Calibrator 30 — Siemens Healthcare Diagnostics · Class II
- ADVIA Centaur® Systems Calibrator 30 — Siemens Healthcare Diagnostics · Class II
- Atellica IM Calibrator 30 — Siemens Healthcare Diagnostics · Class II
- Atellica IM Calibrator 30 — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K932955 also covers:
- ADVIA Centaur® Calibrator E — Siemens Healthcare Diagnostics
- ADVIA Centaur® Immunoassay Systems PRGE MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® PRGE — Siemens Healthcare Diagnostics
- ADVIA Centaur® PRGE +E — Siemens Healthcare Diagnostics
- ADVIA Centaur® Progesterone (PRGE) — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems ACS:180® Systems Calibrator E — Siemens Healthcare Diagnostics
- Atellica IM Calibrator E — Siemens Healthcare Diagnostics
- Atellica IM Calibrator E — Siemens Healthcare Diagnostics
- Atellica IM Calibrator E — Siemens Healthcare Diagnostics
- Atellica IM PRGE — Siemens Healthcare Diagnostics
- Atellica IM PRGE — Siemens Healthcare Diagnostics
- Atellica IM PRGE — Siemens Healthcare Diagnostics
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 10abfce0-32f9-4ebd-a7a2-0f9f69e91053 37 fields · synced May 30, 2026