Identity
- Trade Name
- Immunalysis FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Opiates Urine HEIA™ FDA UDI
- Model / Reference
- 307UR-0060W FDA UDI
- Description
- Opiates Urine HEIA™ FDA UDI
Identifiers
- Catalog Number
- 307UR-0060W FDA UDI
- Primary DI / UDI-DI
- 00840937101476 FDA UDI
- 510(k) Number
- K143502 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
Immunalysis by Immunalysis Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143502 also covers:
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 |
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Manufacturer
- Manufacturer
- Immunalysis Corporation
Sources (1)
- FDA UDI 42aec582-9b2c-479b-af60-a01fb1f62e88 36 fields · synced May 30, 2026