Identity
- Trade Name
- AccuSign® PCP card FDA UDI
- Generic Name
- Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- AccuSign® PCP card; 35 Test kit; CE FDA UDI
- Model / Reference
- DOA-205-35-02 FDA UDI
- Description
- AccuSign® PCP card; 35 Test kit; CE FDA UDI
Identifiers
- Catalog Number
- DOA-205-35-02 FDA UDI
- Primary DI / UDI-DI
- 10743816000129 FDA UDI
- 510(k) Number
- K961266 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
No
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
AccuSign® PCP card by Princeton Biomeditech Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Phencyclidine (PCP) IVD, kit, rapid ICT, clinical.
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- UScreen — Guangzhou Decheng Biotechnology Co., LTD · Class II
- Phencyclidine Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD. · U
- SAFECUP III MULTIDRUG N5 — GERMAINE LABORATORIES, INC. · Class II
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class II
Cleared under the same submission
K961266 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
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI 23ab8055-5277-4f9c-a7ac-6c321acd0ce4 37 fields · synced May 29, 2026