Identity
- Trade Name
- ONLINE DAT Lysergic Acid Diethylamide FDA UDI
- Generic Name
- Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent FDA UDI
- Model / Reference
- 08764778190 FDA UDI
Identifiers
- Catalog Number
- 08764778190 FDA UDI
- Primary DI / UDI-DI
- 07613336164891 FDA UDI
- 510(k) Number
- K972250 FDA UDI
- FDA Product Code
- DLB FDA UDI
- GMDN Term
- Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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, reagent
ONLINE DAT Lysergic Acid Diethylamide by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lysergic acid diethylamide (LSD)/LSD metabolite IVD, reagent.
- CEDIA LSD Assay — Microgenics Corporation · Class II
Cleared under the same submission
K972250 also covers:
- Ammonia — Roche Diagnostics Corp.
- Ammonia — Roche Diagnostics Corp.
- Ammonia — Roche Diagnostics Corp.
- Amylase EPS ver2 — Roche Diagnostics Corp.
- Lipase colorimetric assay — Roche Diagnostics Corp.
- Lysergic Acid Diethylamide — Roche Diagnostics Corp.
- UREABUN — Roche Diagnostics Corp.
- Urea/Bun — Roche Diagnostics Corp.
- UreaBUN — Roche Diagnostics Corp.
- UreaBUN — Roche Diagnostics Corp.
- a-Amylase EPS Pancreatic — Roche Diagnostics Corp.
- a-Amylase EPS ver.2 — Roche Diagnostics Corp.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI e7fa4974-646f-4100-ab88-f0a73d7616ca 35 fields · synced May 30, 2026