Identity
- Trade Name
- Pointe Scientific, Inc. Microalbumin Calibrator FDA UDI
- Generic Name
- Microalbumin IVD, calibrator FDA UDI
- Device Name
- Pointe Scientific, Inc. Microalbumin Calibrator is intended to be used for the calibration of Pointe Scientific’s Microalbumin immunoturbidimetric assay for quantitating albumin in urine specimens. For in vitro diagnostic use. FDA UDI
- Model / Reference
- M7562-CAL FDA UDI
- Description
- Pointe Scientific, Inc. Microalbumin Calibrator is intended to be used for the calibration of Pointe Scientific’s Microalbumin immunoturbidimetric assay for quantitating albumin in urine specimens. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- M7562-CAL FDA UDI
- Primary DI / UDI-DI
- 00811727011893 FDA UDI
- 510(k) Number
- K023860 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- Microalbumin IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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: Microalbumin IVD, calibrator
Pointe Scientific, Inc. Microalbumin Calibrator by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K023860 also covers:
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 f520dda1-6fc3-44c9-82f7-ccec14286387 37 fields · synced May 30, 2026