Identity
- Trade Name
- Pointe Methadone Calibrator (1000 ng/mL) FDA UDI
- Generic Name
- Methadone IVD, calibrator FDA UDI
- Device Name
- Pointe Methadone Calibrator (1000 ng/mL) 1 x 5 mL The Pointe Methadone Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methadone Reagent Set (Ref# 60-ME0220-100/60-ME0220-1L) on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-ME0230-5 FDA UDI
- Description
- Pointe Methadone Calibrator (1000 ng/mL) 1 x 5 mL The Pointe Methadone Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methadone Reagent Set (Ref# 60-ME0220-100/60-ME0220-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-ME0230-5 FDA UDI
- Primary DI / UDI-DI
- 00811727017079 FDA UDI
- 510(k) Number
- K023316 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Methadone 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: Methadone IVD, calibrator
Pointe Methadone Calibrator (1000 ng/mL) by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Methadone IVD, calibrator.
- Rapid TOX — American Bio Medica Corp. · Class I
- Methadone DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc. · Class II
- Methadone DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc. · Class II
- Methadone DAU Calibrator, High Calibrator — Lin-Zhi International, Inc. · Class II
- Methadone DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc. · Class II
- Rapid TOX — American Bio Medica Corp. · Class I
- Rapid TOX — American Bio Medica Corp. · U
- Pointe Methadone Calibrator (600 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K023316 also covers:
- Methadone DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Methadone DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Methadone DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Methadone DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Methadone DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Methadone DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Propoxyphene DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Propoxyphene DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Propoxyphene DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Propoxyphene DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Propoxyphene DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Propoxyphene 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 11c806d6-4927-4fb7-a87f-8da2f337cb22 37 fields · synced May 30, 2026