Identity
- Trade Name
- Pointe Phencyclidine (PCP) Calibrator (100 ng/mL) FDA UDI
- Generic Name
- Phencyclidine (PCP) IVD, calibrator FDA UDI
- Device Name
- Pointe Phencyclidine (PCP) Calibrator (100 ng/mL) 1 x 5 mL The Pointe Phencyclidine (PCP) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Phencyclidine (PCP) Reagent Set (Ref# 60-PH0020-100/60-PH0020-1L) on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-PC0030-5 FDA UDI
- Description
- Pointe Phencyclidine (PCP) Calibrator (100 ng/mL) 1 x 5 mL The Pointe Phencyclidine (PCP) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Phencyclidine (PCP) Reagent Set (Ref# 60-PH0020-100/60-PH0020-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-PC0030-5 FDA UDI
- Primary DI / UDI-DI
- 00811727016508 FDA UDI
- 510(k) Number
- K020769 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Phencyclidine (PCP) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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, calibrator
Pointe Phencyclidine (PCP) Calibrator (100 ng/mL) by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phencyclidine (PCP) IVD, calibrator.
- Rapid TOX — American Bio Medica Corp. · Class I
- Phencyclidine DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc. · Class II
- Phencyclidine DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc. · Class II
- Phencyclidine DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc. · Class II
- Phencyclidine DAU Calibrator, High Calibrator — Lin-Zhi International, Inc. · Class II
- Pointe Phencyclidine (PCP) Calibrator (25 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
- Pointe Phencyclidine (PCP) Calibrator (50 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
- Pointe Phencyclidine (PCP) Calibrator (12.5 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K020769 also covers:
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- Amphetamines DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Amphetamines DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Amphetamines DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
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- Amphetamines DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Cocaine Metabolite DAU Control, Level 2 Control — Lin-Zhi International, Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI a65af38c-d083-40d5-a0f6-8a1aad4e8fc6 37 fields · synced May 30, 2026