Identity
- Trade Name
- Syva® Emit® tox™ Salicylic Acid Assay FDA UDI
- Generic Name
- Salicylate IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Syva® Emit® tox Salicylic Acid Assay FDA UDI
- Model / Reference
- 10445392 FDA UDI
- Description
- Syva® Emit® tox Salicylic Acid Assay FDA UDI
Identifiers
- Catalog Number
- 7S019UL FDA UDI
- Primary DI / UDI-DI
- 00842768001611 FDA UDI
- 510(k) Number
- K011878 FDA UDI
- FDA Product Code
- DKJ FDA UDI
- GMDN Term
- Salicylate IVD, kit, enzyme immunoassay (EIA) 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 immunoassay (EIA)
Syva® Emit® tox™ Salicylic Acid Assay 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 immunoassay (EIA).
Cleared under the same submission
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 5d5dc308-9054-40a3-a7e0-2b6820a389c0 37 fields · synced Jun 8, 2026