Identity
- Trade Name
- PCP Intercept 100 Plate Kit FDA UDI
- Generic Name
- Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 1154IC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00608337000733 FDA UDI
- 510(k) Number
- K000399 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
No
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, enzyme immunoassay (EIA)
PCP Intercept 100 Plate Kit by OraSure Technologies, 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).
- CAROLINA LIQUID CHEMISTRIES CORP.® PCP RGT. KIT BL-414 — Carolina Liquid Chemistries Corp. · U
- PCP Rapid Test Cassette — ACRO BIOTECH Inc. · U
- Immunalysis — Immunalysis Corporation · U
- Syva® Emit® II Plus Phencyclidine Assay — Siemens Healthcare Diagnostics · U
- ARCHITECT — Abbott Laboratories, Inc. · U
- Phencyclidine Enzyme Immunoassay — Lin-Zhi International, Inc. · U
- Dimension® Flex® reagent cartridge PCP — Siemens Healthcare Diagnostics · U
- Dimension Vista® Flex® reagent cartridge PCP — Siemens Healthcare Diagnostics · U
Cleared under the same submission
K000399 also covers:
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
- OraSure Technologies, Inc.
Sources (1)
- FDA UDI 691f473a-6bb1-4168-9c2b-86c5cc59a090 35 fields · synced Jun 9, 2026