Identity
- Trade Name
- Immunalysis Corporation FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, reagent FDA UDI
- Device Name
- Immunalysis Corporation Morphine Specific Conjugate (25 mL) FDA UDI
- Model / Reference
- FC-213-25 FDA UDI
- Description
- Immunalysis Corporation Morphine Specific Conjugate (25 mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840937106501 FDA UDI
- GMDN Term
- Opiate/opiate metabolite IVD, reagent FDA UDI
Classification
- Commercial Distribution
- Not 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
Yes
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
Immunalysis Corporation's Morphine Specific Conjugate (25 mL) device is a reliable and accurate tool for detecting opiate and/or opiate metabolites in clinical specimens. The device uses a proprietary conjugate to selectively bind to morphine and other opioid compounds, enabling precise quantification.
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Immunalysis Corporation
Sources (1)
- FDA UDI c9b8a051-e87a-4b79-825b-ea0dd4771b9d 35 fields · synced Jul 13, 2026