Identity
- Trade Name
- Immunalysis FDA UDI
- Generic Name
- Benzodiazepine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Benzodiazepines Urine HEIA™ FDA UDI
- Model / Reference
- 314UR-0025 FDA UDI
- Description
- Benzodiazepines Urine HEIA™ FDA UDI
Identifiers
- Catalog Number
- 314UR-0025 FDA UDI
- Primary DI / UDI-DI
- 00840937102077 FDA UDI
- 510(k) Number
- K151771 FDA UDI
- FDA Product Code
- JXM FDA UDI
- GMDN Term
- Benzodiazepine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3170 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: Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Immunalysis by Immunalysis Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Benzodiazepine group IVD, kit, enzyme immunoassay (EIA).
- CAROLINA LIQUID CHEMISTRIES CORP.® TBENZ RGT KIT Product No. ST441 — Carolina Liquid Chemistries Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® BENZ RGT. KIT AU-418 — Carolina Liquid Chemistries Corp. · Class II
- VeriQuick — FOURSTAR GROUP INC. · Class II
- Benzodiazepine Intercept 2 Plate Kit — OraSure Technologies, Inc. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® BENZ RGT. KIT ST418 — Carolina Liquid Chemistries Corp. · Class II
- Syva® Emit® tox™ Serum Benzodiazepine Assay — Siemens Healthcare Diagnostics · Class II
- VeriQuick — FOURSTAR GROUP INC. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® BENZ RGT KIT Product No. DT418 — Carolina Liquid Chemistries Corp. · Class II
Cleared under the same submission
K151771 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immunalysis Corporation
Sources (1)
- FDA UDI aa31da46-5493-4382-a6c6-2df7955475ba 36 fields · synced Jun 8, 2026