Identity
- Trade Name
- Immunalysis FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, control FDA UDI
- Device Name
- Hydrocodone Oral Fluid Control Set FDA UDI
- Model / Reference
- 3020-15 FDA UDI
- Description
- Hydrocodone Oral Fluid Control Set FDA UDI
Identifiers
- Catalog Number
- 3020-15 FDA UDI
- Primary DI / UDI-DI
- 00840937114674 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- Opiate/opiate metabolite IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 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
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
Yes
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, control
Immunalysis by Immunalysis Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Hydrocodone 100 DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Immunalysis Corporation
Sources (1)
- FDA UDI 34f1f822-1a8c-4b5f-a194-2056b23b0b88 35 fields · synced Jun 6, 2026