Identity
- Trade Name
- ADVIA Centaur® Systems iPTH Calibrator FDA UDI
- Generic Name
- Parathyroid hormone (PTH) IVD, calibrator FDA UDI
- Device Name
- PTH Intact - CENTAUR - CAL - 2x2x1mL FDA UDI
- Model / Reference
- 10492394 FDA UDI
- Description
- PTH Intact - CENTAUR - CAL - 2x2x1mL FDA UDI
Identifiers
- Catalog Number
- 10492394 FDA UDI
- Primary DI / UDI-DI
- 00630414579207 FDA UDI
- 510(k) Number
- K020217 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Parathyroid hormone (PTH) 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: Parathyroid hormone (PTH) IVD, calibrator
ADVIA Centaur® Systems iPTH Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Parathyroid hormone (PTH) IVD, calibrator.
- ARCHITECT — Abbott · Class II
- CalSet PTH — Roche Diagnostics Corp. · Class II
- Alinity — Abbott · Class II
- IDS-iSYS Intact PTH Calibration Verifiers — Immunodiagnostic Systems , Ltd. · Class I
- CalSet PTH STAT — Roche Diagnostics Corp. · Class I
- CalSet II PTH — Roche Diagnostics Corp. · Class II
- CalSet PTH — Roche Diagnostics Corp. · Class I
- CalSet PTH STAT — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K020217 also covers:
- IMMULITE® Systems PTH Calibration Verification Material Intact PTH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- ADVIA Centaur® Systems QC iPTH — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems iPTH Calibrator — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems iPTH Calibrator — Siemens Healthcare Diagnostics
- ADVIA Centaur® iPTH Calibrator — Siemens Healthcare Diagnostics
- ADVIA Centaur® iPTH MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® iPTH QC Ref — 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 9e7c4b7d-46ef-4c3a-b545-dbe753d876d5 37 fields · synced May 31, 2026