Identity
- Trade Name
- ADVIA Centaur® Multi-Diluent 12 FDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- Multidil 12 CSA - CENTAUR - CONS - 1x20mL FDA UDI
- Model / Reference
- 10335692 FDA UDI
- Description
- Multidil 12 CSA - CENTAUR - CONS - 1x20mL FDA UDI
Identifiers
- Catalog Number
- 4786546 FDA UDI
- Primary DI / UDI-DI
- 00630414525549 FDA UDI
- 510(k) Number
- K071455 FDA UDI
- FDA Product Code
- MKW FDA UDI
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1235 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: Buffered sample diluent IVD
ADVIA Centaur® Multi-Diluent 12 by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Buffered sample diluent IVD.
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- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Diluent — Biogenex Laboratories, Inc. · Class I
- IMMULITE®/IMMULITE® 1000 Systems CRP Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE® 2000 Systems HCY Homocysteine Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K071455 also covers:
- ADVIA Centaur® CsA — Siemens Healthcare Diagnostics
- ADVIA Centaur® CsA CAL — Siemens Healthcare Diagnostics
- ADVIA Centaur® CsA PRE Pretreatment — Siemens Healthcare Diagnostics
- Atellica IM CsA — Siemens Healthcare Diagnostics
- Atellica IM CsA Calibrator — Siemens Healthcare Diagnostics
- Atellica IM CsA PRE Pretreatment — Siemens Healthcare Diagnostics
- Atellica IM Multi-Diluent 12 — 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 091885ca-8853-45fb-9006-bee0b6f0ad9a 37 fields · synced May 30, 2026