Identity
- Trade Name
- ADVIA Centaur® Calibrator A FDA UDI
- Generic Name
- Multiple human hormone IVD, calibrator FDA UDI
- Device Name
- Thyroid (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL FDA UDI
- Model / Reference
- 10285905 FDA UDI
- Description
- Thyroid (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL FDA UDI
Identifiers
- Catalog Number
- 4800840 FDA UDI
- Primary DI / UDI-DI
- 00630414555331 FDA UDI
- 510(k) Number
- K961510 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Multiple human hormone IVD, calibrator 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: Multiple human hormone IVD, calibrator
ADVIA Centaur® Calibrator A by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple human hormone IVD, calibrator.
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- LIPID CALIBRATOR, LYOPHILIZED — CLINIQA CORPORATION
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Cleared under the same submission
K961510 also covers:
- ADVIA Centaur® ACS:180® Calibrator A — Siemens Healthcare Diagnostics
- ADVIA Centaur® ACS:180® Calibrator A — Siemens Healthcare Diagnostics
- Atellica IM Calibrator A — Siemens Healthcare Diagnostics
- Atellica IM Calibrator A — Siemens Healthcare Diagnostics
- Atellica IM Calibrator A — 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 cdbe05b7-c564-4592-9b81-ea5b34bb0801 37 fields · synced May 31, 2026