Identity
- Trade Name
- Immunalysis FDA UDI
- Generic Name
- Amphetamine-specific IVD, control FDA UDI
- Device Name
- Amphetamine Urine Control Set 1 FDA UDI
- Model / Reference
- C309UR-5-2-500 FDA UDI
- Description
- Amphetamine Urine Control Set 1 FDA UDI
Identifiers
- Catalog Number
- C309UR-5-2-500 FDA UDI
- Primary DI / UDI-DI
- 00840937103586 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Amphetamine-specific 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: Amphetamine-specific IVD, control
Immunalysis by Immunalysis Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amphetamine-specific IVD, control.
- Oral Fluid Amphetamine Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Pointe Ecstasy (MDMA) Control (625 ng/mL) Level 2 — POINTE SCIENTIFIC, INC. · Class I
- Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1 — POINTE SCIENTIFIC, INC. · Class I
- Oral Fluid Amphetamine Control, Level 1 Control — Lin-Zhi International, Inc. · 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 c9adca54-25a2-4dd4-825e-720cb04f03b0 35 fields · synced Jun 6, 2026