Identity
- Trade Name
- Syva® Emit® 2000 Sirolimus Assay FDA UDI
- Generic Name
- Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Syva® Emit® 2000 Sirolimus Assay FDA UDI
- Model / Reference
- 10445401 FDA UDI
- Description
- Syva® Emit® 2000 Sirolimus Assay FDA UDI
Identifiers
- Catalog Number
- 8S019UL FDA UDI
- Primary DI / UDI-DI
- 00842768029615 FDA UDI
- 510(k) Number
- K083487 FDA UDI
- FDA Product Code
- NRP FDA UDI
- GMDN Term
- Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3840 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: Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 2000 Sirolimus Assay by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rapamycin (sirolimus) therapeutic drug monitoring 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 1eee08d6-c0a9-4dc7-94c1-02a715e29d74 37 fields · synced May 30, 2026