Identity
- Trade Name
- CEDIA Cocaine Assay FDA UDI
- Generic Name
- Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA), FDA UDI
- Model / Reference
- 100086 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883001435 FDA UDI
- FDA Product Code
- DIO FDA UDI
- GMDN Term
- Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA), FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3250 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
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: Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
CEDIA Cocaine Assay by Microgenics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),.
- Syva® Emit® II Plus Cocaine Metabolite Assay — Siemens Healthcare Diagnostics · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® COCM RGT. KIT ST113 — Carolina Liquid Chemistries Corp. · Class II
- Cocaine OraSure 5 Plate Kit — OraSure Technologies, Inc. · Class II
- Dimension Vista® Flex® reagent cartridge COC — Siemens Healthcare Diagnostics · Class II
- Pointe Cocaine Metabolite 150 Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- Cocaine Metabolite Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- Pointe Cocaine Metabolite 150 Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- Cocaine Metabolite 150 Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
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
- Microgenics Corporation
Sources (1)
- FDA UDI 73683398-df8f-43ec-9566-907eca9681d8 32 fields · synced Jun 9, 2026