Identity
- Trade Name
- ADVIA Centaur® PW 4 FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- Probe Wash 4 - CENTAUR - CONS - 1x25mL FDA UDI
- Model / Reference
- 10321290 FDA UDI
- Description
- Probe Wash 4 - CENTAUR - CONS - 1x25mL FDA UDI
Identifiers
- Catalog Number
- 4750940 FDA UDI
- Primary DI / UDI-DI
- 00630414525464 FDA UDI
- 510(k) Number
- K041133 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Buffered wash solution 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: Buffered wash solution IVD
ADVIA Centaur® PW 4 by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered wash solution IVD.
- CELL-DYN — Abbott Laboratories, Inc. · Class I
- VENTANA HE 600 Wash — Ventana Medical Systems · Class I
- TBS Auto Wash Buffer 20X — BIOCARE MEDICAL, LLC · Class I
- COBAS® AMPLICOR Wash Buffer — Roche Molecular Systems, Inc.
- ISE Buffer Reagent — DIAMOND DIAGNOSTICS Inc
- V8 Maintenance Buffer Kit — Helena Laboratories, Corp. · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- cobas® Sample Prep Buffer — Roche Molecular Systems, Inc. · Class I
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® CP Reagent 1 and 2 Set — 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 e3d586c5-38d5-4ddf-93c7-69cdf595ff19 37 fields · synced Jun 6, 2026