Identity
- Trade Name
- Dimension Vista® Flex® reagent cartridge PCP FDA UDI
- Generic Name
- Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Urine Phencyclidine Screen Flex® reagent cartridge, 120 tests FDA UDI
- Model / Reference
- 10445115 FDA UDI
- Description
- Urine Phencyclidine Screen Flex® reagent cartridge, 120 tests FDA UDI
Identifiers
- Catalog Number
- K5094 FDA UDI
- Primary DI / UDI-DI
- 00842768015380 FDA UDI
- 510(k) Number
- K062128 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
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)
Dimension Vista® Flex® reagent cartridge PCP by Siemens Healthcare Diagnostics — 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
- ARCHITECT — Abbott Laboratories, Inc. · U
- Phencyclidine Enzyme Immunoassay — Lin-Zhi International, Inc. · U
- VITROS — Ortho-Clinical Diagnostics · U
- Immunalysis — Immunalysis Corporation · U
- Alinity — Abbott Laboratories, Inc. · U
Cleared under the same submission
K062128 also covers:
- Dimension Vista® Flex® reagent cartridge AMPH — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge BARB — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge BENZ — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge COC — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge EXTC — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge METH — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge OPI — Siemens Healthcare Diagnostics
- Dimension Vista® Flex® reagent cartridge THC — Siemens Healthcare Diagnostics
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 3efe780a-155f-4244-819c-a082e1c0f5c0 37 fields · synced Jun 8, 2026