Identity
- Trade Name
- ADVIA® Chemistry Cuvette Conditioner FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- Cuvette conditioner - ADVIA Chem. - CONS - 1x1000mL FDA UDI
- Model / Reference
- 10311854 FDA UDI
- Description
- Cuvette conditioner - ADVIA Chem. - CONS - 1x1000mL FDA UDI
Identifiers
- Catalog Number
- B01-4179-51 FDA UDI
- Primary DI / UDI-DI
- 00630414210025 FDA UDI
- FDA Product Code
- JCC FDA UDI
- GMDN Term
- Buffered wash solution IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
Yes
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® Chemistry Cuvette Conditioner by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Buffered wash solution IVD.
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- 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
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 857b0f6b-ee15-4a28-a766-f0e9a0d97150 36 fields · synced Jun 1, 2026