Identity
- Trade Name
- ADVIA® Chemistry SAL Salicylate Reagents FDA UDI
- Generic Name
- Salicylate IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- Salicylate - ADVIA Chem. - RGT - 4x150 tests FDA UDI
- Model / Reference
- 10327382 FDA UDI
- Description
- Salicylate - ADVIA Chem. - RGT - 4x150 tests FDA UDI
Identifiers
- Catalog Number
- 7989456 FDA UDI
- Primary DI / UDI-DI
- 00630414498959 FDA UDI
- 510(k) Number
- K093939 FDA UDI
- FDA Product Code
- DKJ FDA UDI
- GMDN Term
- Salicylate IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3830 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: Salicylate IVD, kit, enzyme spectrophotometry
ADVIA® Chemistry SAL Salicylate Reagents by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Salicylate IVD, kit, enzyme spectrophotometry.
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Cleared under the same submission
K093939 also covers:
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 44f006e6-80cd-476f-9d44-7a1dfa5c6c76 37 fields · synced May 31, 2026