Identity
- Trade Name
- AIMSCREEN MULTIDRUG 12 FDA UDI
- Generic Name
- Tricyclic antidepressant IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Marijuana (THC), Methadone (MTD), Opiates (OPI), Phencyclidine (PCP), Barbiturates (BAR), Benzodiazpines (BZD), Ecstasy (MDMA) , Oxycodone (OXY), Propoxyphene (PPX). FDA UDI
- Model / Reference
- 40135 FDA UDI
- Description
- Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Marijuana (THC), Methadone (MTD), Opiates (OPI), Phencyclidine (PCP), Barbiturates (BAR), Benzodiazpines (BZD), Ecstasy (MDMA) , Oxycodone (OXY), Propoxyphene (PPX). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684401351 FDA UDI
- FDA Product Code
- LFG FDA UDIJXN FDA UDIDIS FDA UDILCM FDA UDIJXM FDA UDIDKZ FDA UDIDJG FDA UDILAF FDA UDIDIO FDA UDILDJ FDA UDI
- GMDN Term
- Tricyclic antidepressant IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3910 FDA UDI862.3700 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3100 FDA UDI862.3650 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3870 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: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinicalCocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalOpiate/opiate metabolite IVD, kit, rapid ICT, clinicalAmphetamine-specific IVD, kit, rapid ICT, clinical
Aimscreen Multidrug 12 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
- Pointe Propoxyphene (PPX) Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Germaine Laboratories, Inc.
Sources (1)
- FDA UDI 4b857e2e-b2f5-4baf-a307-ccb482146cf1 33 fields · synced May 30, 2026