Identity
- Trade Name
- CEDIA Opiate Assay FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- CEDIA Opiate Assay EUDAMED
- Model / Reference
- 100098 EUDAMEDFDA UDI10016429 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883001510 EUDAMEDFDA UDI00884883012554 FDA UDI
- Basic UDI-DI
- B-00884883001510 EUDAMED
- FDA Product Code
- DJG FDA UDI
- EMDN Code
- W0102090113 OPIATES EUDAMED
- GMDN Term
- Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.3650 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: Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
CEDIA Opiate Assay by Microgenics Corporation — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA).
- CAROLINA LIQUID CHEMISTRIES CORP.® OP RGT. KIT BL-411A — Carolina Liquid Chemistries Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Syva® Emit® II Plus Opiate Assay — Siemens Healthcare Diagnostics · Class II
- ARK™ Fentanyl Assay — ARK DIAGNOSTICS INC · Class II
- Immunalysis — Immunalysis Corporation · Class II
- Immunalysis — Immunalysis Corporation · Class II
- Syva® Emit® II Plus Opiate Assay — Siemens Healthcare Diagnostics · Class II
- Immunalysis — Immunalysis Corporation · Class II
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 (3)
- FDA UDI c03f1e4c-0500-4ab5-9ebf-36376773101a 32 fields · synced Jul 12, 2026
- FDA UDI e1ec3b9d-8b88-4861-8042-6b8b458494b2 32 fields · synced May 30, 2026
- EUDAMED a6dc24b7-8022-4cde-858c-a33cd6234136 61 fields · synced Jul 12, 2026