Identity
- Trade Name
- ADVIA® Chemistry ISE Detergent Solution FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- ISE DET Solution - ADVIA Chem. - CONS - 2x100mL FDA UDI
- Model / Reference
- 10311851 FDA UDI
- Description
- ISE DET Solution - ADVIA Chem. - CONS - 2x100mL FDA UDI
Identifiers
- Catalog Number
- B01-4174-52 FDA UDI
- Primary DI / UDI-DI
- 00630414209982 FDA UDI
- 510(k) Number
- K990346 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system 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: Wash/cleaning solution IVD, automated/semi-automated system
ADVIA® Chemistry ISE Detergent Solution by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K990346 also covers:
- ADVIA Chemistry Systems 70-mL Wedges - Yellow — Siemens Healthcare Diagnostics
- ADVIA® 1650 Chemistry System Ref. — Siemens Healthcare Diagnostics
- ADVIA® 1800 Analyzer — Siemens Healthcare Diagnostics
- ADVIA® Chemistry Cuvette Detergent — Siemens Healthcare Diagnostics
- ADVIA® Chemistry Cuvette Wash Solution — Siemens Healthcare Diagnostics
- ADVIA® Chemistry Electrode CL — Siemens Healthcare Diagnostics
- ADVIA® Chemistry Electrode K — Siemens Healthcare Diagnostics
- ADVIA® Chemistry Electrode NA — Siemens Healthcare Diagnostics
- ADVIA® Chemistry ISE Baseline Solution - XPT only — Siemens Healthcare Diagnostics
- ADVIA® Chemistry ISE Serum Standard Set — Siemens Healthcare Diagnostics
- ADVIA® Chemistry ISE Urine Standard Set — Siemens Healthcare Diagnostics
- ADVIA® Chemistry Probe Wash 0 - XPT only — 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 60d7fd96-b284-4d91-90ed-16f427d7ab4d 37 fields · synced Jun 1, 2026