Identity
- Trade Name
- Immunalysis FDA UDI
- Generic Name
- Amphetamine-specific IVD, calibrator FDA UDI
- Device Name
- Amphetamine Urine Calibrator Set FDA UDI
- Model / Reference
- C309UR-5-5 FDA UDI
- Description
- Amphetamine Urine Calibrator Set FDA UDI
Identifiers
- Catalog Number
- C309UR-5-5 FDA UDI
- Primary DI / UDI-DI
- 00840937103609 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Amphetamine-specific IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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, calibrator
Immunalysis by Immunalysis Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Amphetamine-specific IVD, calibrator.
- Oral Fluid Amphetamine Calibrator, Low Calibrator — Lin-Zhi International, Inc. · Class II
- Pointe Ecstasy (MDMA) Calibrator (500 ng/mL) Cutoff — POINTE SCIENTIFIC, INC. · Class II
- Oral Fluid Amphetamine Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc. · Class II
- Rapid TOX — American Bio Medica Corp. · Class I
- Oral Fluid Amphetamine Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc. · Class II
- Oral Fluid Amphetamine Calibrator, High Calibrator — Lin-Zhi International, Inc. · Class II
- Pointe Ecstasy (MDMA) Calibrator (750 ng/mL) Intermediate — POINTE SCIENTIFIC, INC. · Class II
- Pointe Ecstasy (MDMA) Calibrator (1000 ng/mL) High — POINTE SCIENTIFIC, INC. · Class II
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 d188646d-53c8-4c8a-97cf-09be7d961089 35 fields · synced Jun 8, 2026