Identity
- Trade Name
- Alere iScreen Dx FDA UDI
- Generic Name
- Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Urine Drug Screen Card for detection of Phencyclidine (PCP) single drug, CLIA Waived FDA UDI
- Model / Reference
- IS1 PCP-DX FDA UDI
- Description
- Urine Drug Screen Card for detection of Phencyclidine (PCP) single drug, CLIA Waived FDA UDI
Identifiers
- Catalog Number
- IS1 PCP-DX FDA UDI
- Primary DI / UDI-DI
- 00817405020034 FDA UDI
- 510(k) Number
- K022355 FDA UDI
- FDA Product Code
- LCM FDA UDI
- GMDN Term
- Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U 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
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: Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Alere iScreen Dx by Instant Technologies, 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.
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- Status DS™ 9 card — PRINCETON BIOMEDITECH CORP. · Class II
- N/M — IDUN SOLUTIONS LLC · Class II
- AIMSCREEN PCP — GERMAINE LABORATORIES, INC. · U
- UScreen — Guangzhou Decheng Biotechnology Co., LTD · Class II
- Phencyclidine Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD. · U
Cleared under the same submission
K022355 also covers:
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- CLIAwaived — CLIAWAIVED,INC.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
- Alere iScreen Dx — Instant Technologies, Inc.
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 |
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Manufacturer
- Manufacturer
- Instant Technologies, Inc.
Sources (1)
- FDA UDI 91bb5335-c9d7-4603-933e-74bcf8c6707f 37 fields · synced May 30, 2026