Identity
- Trade Name
- Pointe Multi-Analyte E DAU High Calibrator FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, calibrator FDA UDI
- Device Name
- Pointe Multi-Analyte E DAU High Calibrator 1 x 15 mL The Pointe Multi-Analyte Set E Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of secobarbital, norbuprenorphine, methadone, and phencyclidine in human urineon a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-MA1790-15 FDA UDI
- Description
- Pointe Multi-Analyte E DAU High Calibrator 1 x 15 mL The Pointe Multi-Analyte Set E Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of secobarbital, norbuprenorphine, methadone, and phencyclidine in human urineon a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-MA1790-15 FDA UDI
- Primary DI / UDI-DI
- 00811727017727 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 E DAU High Calibrator by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple drugs of abuse IVD, calibrator.
- Preciset DAT Plus I — Roche Diagnostics Corp. · Class II
- Emit II Plus Specialty Multi Drug Calibrator/Control Level 4 — Siemens Healthcare Diagnostics · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Syva® Emit® tox™ Serum Calibrators — Siemens Healthcare Diagnostics · Class II
- Syva® Emit® Calibrator/Control Level 5 — Siemens Healthcare Diagnostics · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Preciset TDM II — Roche Diagnostics Corp. · Class II
- Alinity — Abbott Laboratories, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 51bb24c5-8ec7-4b3b-b5c5-58f72e1bf495 36 fields · synced May 31, 2026