Identity
- Trade Name
- BN II Additive FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- Washing Solution (concentrate) for cleaning the cuvettes in the BN II System FDA UDI
- Model / Reference
- 10446098 FDA UDI
- Description
- Washing Solution (concentrate) for cleaning the cuvettes in the BN II System FDA UDI
Identifiers
- Catalog Number
- OQKY61 FDA UDI
- Primary DI / UDI-DI
- 00842768007781 FDA UDI
- 510(k) Number
- K001647 FDA UDI
- FDA Product Code
- JZW FDA UDI
- GMDN Term
- Buffered wash solution IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.4540 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
BN II Additive by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered wash solution IVD.
- ADVIA Centaur® Wash 1 — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® PW3 — Siemens Healthcare Diagnostics · Class I
- 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
- ADVIA Centaur® PW 4 — Siemens Healthcare Diagnostics · Class I
- COBAS® AMPLICOR Wash Buffer — Roche Molecular Systems, Inc.
- ISE Buffer Reagent — DIAMOND DIAGNOSTICS Inc
Cleared under the same submission
K001647 also covers:
- BN ProSpec® System — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Cleaner SCS — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Cuvette Segments for BN ProSpec® — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Evaporation Caps for Control Vials (2.5 mL) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- N Evaporation Caps for Reagent Vials (5 ml) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 Products Ltd
Sources (1)
- FDA UDI d009088f-6226-4aa0-9428-420649a9d474 37 fields · synced May 30, 2026