Identity
- Trade Name
- SAFECUP II MULTIDRUG N5 FDA UDI
- Generic Name
- Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, AMP, THC, OPI, PCP (cocaine, amphetamine, marijuana, opiates, Phencyclidine). FDA UDI
- Model / Reference
- 45455 FDA UDI
- Description
- Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, AMP, THC, OPI, PCP (cocaine, amphetamine, marijuana, opiates, Phencyclidine). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684454555 FDA UDI
- FDA Product Code
- LCM FDA UDIDJG FDA UDIDKZ FDA UDIDIO FDA UDILDJ FDA UDI
- GMDN Term
- Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3100 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
Safecup Ii Multidrug N5 by Germaine Laboratories, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phencyclidine (PCP) IVD, kit, rapid ICT, clinical.
- BluRapids™ — MERCEDES MEDICAL LLC · Class II
- AccuSign® PCP card — PRINCETON BIOMEDITECH CORP. · U
- Status DS™ 9 card — PRINCETON BIOMEDITECH CORP. · Class II
- N/M — IDUN SOLUTIONS LLC · Class II
- UScreen — Guangzhou Decheng Biotechnology Co., LTD · Class II
- Phencyclidine Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD. · U
- AccuSign® PCP card — PRINCETON BIOMEDITECH CORP. · U
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · 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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Germaine Laboratories, Inc.
Sources (1)
- FDA UDI 251b345e-5471-4c5f-a06a-730168116349 33 fields · synced May 30, 2026