Identity
- Trade Name
- Syva® Emit® LSD Control Level 2 FDA UDI
- Generic Name
- Lysergic acid diethylamide (LSD)/LSD metabolite IVD, control FDA UDI
- Device Name
- Syva® Emit® LSD Control Level 2 FDA UDI
- Model / Reference
- 10445461 FDA UDI
- Description
- Syva® Emit® LSD Control Level 2 FDA UDI
Identifiers
- Catalog Number
- 9L519UL FDA UDI
- Primary DI / UDI-DI
- 00842768002106 FDA UDI
- 510(k) Number
- K955448 FDA UDI
- FDA Product Code
- DLB FDA UDI
- GMDN Term
- Lysergic acid diethylamide (LSD)/LSD metabolite IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3580 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: Lysergic acid diethylamide (LSD)/LSD metabolite IVD, control
Syva® Emit® LSD Control Level 2 by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lysergic acid diethylamide (LSD)/LSD metabolite IVD, control.
- LSD CalibrationControl Pack — Roche Diagnostics Corp. · Class II
- Syva® Emit® LSD Control Level 1 — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K955448 also covers:
- Syva® Emit® II LSD Assay — Siemens Healthcare Diagnostics
- Syva® Emit® LSD 0 ng/mL Calibrator — Siemens Healthcare Diagnostics
- Syva® Emit® LSD 0.5 ng/mL Calibrator — Siemens Healthcare Diagnostics
- Syva® Emit® LSD 1.5 ng/mL Calibrator — Siemens Healthcare Diagnostics
- Syva® Emit® LSD 2.5 ng/mL Calibrator — Siemens Healthcare Diagnostics
- Syva® Emit® LSD Control Level 1 — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 527d97a5-dd8a-40b2-8f42-97ea3f228d15 37 fields · synced May 30, 2026