Identity
- Trade Name
- ADVIA Centaur® CP Reagent 1 and 2 Set FDA UDI
- Generic Name
- Chemiluminescent immunoassay signal generation kit IVD FDA UDI
- Device Name
- Reagent 1 and 2 set - CENTAUR - CONS - 1000 Best. FDA UDI
- Model / Reference
- 10313526 FDA UDI
- Description
- Reagent 1 and 2 set - CENTAUR - CONS - 1000 Best. FDA UDI
Identifiers
- Catalog Number
- 497043 FDA UDI
- Primary DI / UDI-DI
- 00630414503875 FDA UDI
- 510(k) Number
- K041133 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Chemiluminescent immunoassay signal generation kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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: Chemiluminescent immunoassay signal generation kit IVD
ADVIA Centaur® CP Reagent 1 and 2 Set by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Chemiluminescent immunoassay signal generation kit IVD.
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Cleared under the same submission
K041133 also covers:
- ADVIA Centaur® Acid Base Reagents — Siemens Healthcare Diagnostics
- ADVIA Centaur® Ancillary Probe Wash 1 — Siemens Healthcare Diagnostics
- ADVIA Centaur® Ancillary Probe Wash 2 — Siemens Healthcare Diagnostics
- ADVIA Centaur® CP Immunoassay System — Siemens Healthcare Diagnostics
- ADVIA Centaur® CP Instrument — Siemens Healthcare Diagnostics
- ADVIA Centaur® PW 4 — Siemens Healthcare Diagnostics
- ADVIA Centaur® PW3 — Siemens Healthcare Diagnostics
- ADVIA Centaur® T3 — Siemens Healthcare Diagnostics
- ADVIA Centaur® T3 — Siemens Healthcare Diagnostics
- ADVIA Centaur® T3 DIL — Siemens Healthcare Diagnostics
- ADVIA Centaur® T3 MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Wash 1 — 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 5b9e2f10-2e72-43ed-8a4a-094e1725bab1 37 fields · synced Jun 6, 2026