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Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, calibrator FDA UDI
- Device Name
- Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator 1 x 15 mL The Pointe Multi-Analyte Set D Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs ofabuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, morphine, oxazepam, and oxycodone in human urine on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-MA1746-15 FDA UDI
- Description
- Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator 1 x 15 mL The Pointe Multi-Analyte Set D Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs ofabuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, morphine, oxazepam, and oxycodone in human urine on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-MA1746-15 FDA UDI
- Primary DI / UDI-DI
- 00811727017635 FDA UDI
- FDA Product Code
- DKB FDA UDI
- GMDN Term
- Multiple drugs of abuse 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple drugs of abuse IVD, calibrator
Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 a35b4358-52f5-4b96-a793-9d81b3b26fda 36 fields · synced May 30, 2026