Identity
- Trade Name
- AIMSCREEN PPX FDA UDI
- Generic Name
- Propoxyphene IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Lateral flow immunoassay for the detection of Propoxyphene (PPX) in urine. FDA UDI
- Model / Reference
- 49525 FDA UDI
- Description
- Lateral flow immunoassay for the detection of Propoxyphene (PPX) in urine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684495251 FDA UDI
- FDA Product Code
- JXN FDA UDI
- GMDN Term
- Propoxyphene IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
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: Propoxyphene IVD, kit, enzyme immunoassay (EIA)
Aimscreen Ppx by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Propoxyphene IVD, kit, enzyme immunoassay (EIA).
- Alinity — Abbott Laboratories, Inc. · Class II
- Syva® Emit® II Plus Propoxyphene Assay — Siemens Healthcare Diagnostics · Class II
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- INSTANT-VIEW Propoxyphene (PPX) Urine Cassette Test — Alfa Scientific Designs, Inc. · Class II
- Syva® Emit® II Plus Propoxyphene Assay — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® PROX RGT. KIT AU-416 — Carolina Liquid Chemistries Corp. · Class II
- Syva® Emit® II Plus Propoxyphene Assay — Siemens Healthcare Diagnostics · 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
- Germaine Laboratories, Inc.
Sources (1)
- FDA UDI c9390cf5-fbe1-4ff6-aeef-1531c256d406 33 fields · synced May 30, 2026