Identity
- Trade Name
- CEDIA LSD Assay FDA UDI
- Generic Name
- Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent FDA UDI
- Device Name
- CEDIA LSD Assay EUDAMED
- Model / Reference
- 1732137 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883005679 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883005679 EUDAMED
- 510(k) Number
- K955814 FDA UDI
- FDA Product Code
- DLB FDA UDI
- EMDN Code
- W0102090109 LYSERGIC ACID DIETHYLAMIDE EUDAMED
- GMDN Term
- Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3580 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent
CEDIA LSD Assay by Microgenics Corporation — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microgenics Corporation
Sources (2)
- FDA UDI 55460415-3b6d-47ef-96b2-b5e81e53b23a 33 fields · synced Jul 8, 2026
- EUDAMED fefca06e-ddb4-4151-a9cc-fbc6b398b5bd 61 fields · synced Jul 8, 2026