Identity
- Trade Name
- Immunalysis Corporation FDA UDI
- Generic Name
- Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Immunalysis Corporation Ketamine Urine HEIA Kit 60 mL Wedge FDA UDI
- Model / Reference
- 340UR-0060W FDA UDI
- Description
- Immunalysis Corporation Ketamine Urine HEIA Kit 60 mL Wedge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840937108437 FDA UDI
- GMDN Term
- Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
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
Category: Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA)
Immunalysis Corporation by Immunalysis Corporation — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA).
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 951c794e-0e5d-4f83-8795-cf87991fc3ff 34 fields · synced May 30, 2026