Identity
- Trade Name
- Pointe Phencyclidine (PCP) Reagent Set FDA UDI
- Generic Name
- Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pointe Phencyclidine (PCP) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Phencyclidine (PCP) Reagent Set is intended for the qualitative and semi-quantitative determination of PCP in human urine at a cutoff value of 25 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-PH0020-1L FDA UDI
- Description
- Pointe Phencyclidine (PCP) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Phencyclidine (PCP) Reagent Set is intended for the qualitative and semi-quantitative determination of PCP in human urine at a cutoff value of 25 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-PH0020-1L FDA UDI
- Primary DI / UDI-DI
- 00811727016461 FDA UDI
- 510(k) Number
- K020254 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)
Pointe Phencyclidine (PCP) Reagent Set by Pointe Scientific, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA).
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Cleared under the same submission
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 384f924c-d8b8-4137-9913-8d377c076d6f 37 fields · synced May 29, 2026