Identity
- Trade Name
- Immunalysis FDA UDI
- Generic Name
- Tramadol IVD, control FDA UDI
- Device Name
- Tramadol Urine Control Set FDA UDI
- Model / Reference
- 04Z46-10 FDA UDI
- Description
- Tramadol Urine Control Set FDA UDI
Identifiers
- Catalog Number
- 04Z46-10 FDA UDI
- Primary DI / UDI-DI
- 00840937111581 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- Tramadol 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
Yes
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: Tramadol IVD, control
Immunalysis by Immunalysis Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tramadol IVD, control.
- DRI Tramadol Control Kit — ARK DIAGNOSTICS INC · Class II
- LZI Tramadol Level 1 Control — Lin-Zhi International, Inc. · Class I
- LZI Tramadol Level 2 Control — Lin-Zhi International, Inc. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · 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 789cebdd-83fa-4a06-be08-6cc7269c3ae4 35 fields · synced May 30, 2026