Identity
- Trade Name
- ADVIA Centaur® iPTH QC Ref FDA UDI
- Generic Name
- Parathyroid hormone (PTH) IVD, control FDA UDI
- Device Name
- PTH intact - CENTAUR - CTL - 2 pack (REF) FDA UDI
- Model / Reference
- 10630627 FDA UDI
- Description
- PTH intact - CENTAUR - CTL - 2 pack (REF) FDA UDI
Identifiers
- Catalog Number
- 10630627 FDA UDI
- Primary DI / UDI-DI
- 00630414587479 FDA UDI
- 510(k) Number
- K020217 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Parathyroid hormone (PTH) 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: Parathyroid hormone (PTH) IVD, control
ADVIA Centaur® iPTH QC Ref by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Parathyroid hormone (PTH) IVD, control.
- Audit MicroControls Linearity FD iPTH for Ortho Vitros — Aalto Scientific, Ltd.
- IMMULITE® Systems PTH Calibration Verification Material Intact PTH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — Abbott · Class I
- Audit MicroControls Linearity FD iPTH for Abbott Systems — Aalto Scientific, Ltd.
- IMMULITE® Systems PTH CONTROL Intact PTH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- LIAISON® N-TACT® PTH Gen II Control Set — Diasorin Inc.
- Parathyroid Hormone/PTH Control Slides — BIO SB, INC. · Class I
- AIA-PACK Intact PTH CONTROL SET — Tosoh Corp. · Class I
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® Systems iPTH Calibrator — Siemens Healthcare Diagnostics
- ADVIA Centaur® iPTH Calibrator — Siemens Healthcare Diagnostics
- ADVIA Centaur® iPTH MCM — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI ac2178f6-6318-43c2-8d24-7d6d861e9719 37 fields · synced May 30, 2026