Identity
- Trade Name
- PCP Rapid Test Cassette FDA UDI
- Generic Name
- Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- PCP Rapid Test Cassette FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- PCP Rapid Test Cassette FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853691007656 FDA UDI
- FDA Product Code
- LCM FDA UDI
- GMDN Term
- Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA) 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
No
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: Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
PCP Rapid Test Cassette by ACRO BIOTECH Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA).
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- ARCHITECT — Abbott Laboratories, Inc. · U
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- VITROS — Ortho-Clinical Diagnostics · U
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
- ACRO BIOTECH Inc.
Sources (1)
- FDA UDI 223e3944-e09e-4427-b011-642895934540 33 fields · synced Jun 8, 2026