Identity
- Trade Name
- Dimension® MALB Calibrator FDA UDI
- Generic Name
- Microalbumin IVD, calibrator FDA UDI
- Device Name
- Microalbumin Calibrator, 2x5x1mL FDA UDI
- Model / Reference
- 10445022 FDA UDI
- Description
- Microalbumin Calibrator, 2x5x1mL FDA UDI
Identifiers
- Catalog Number
- DC114 FDA UDI
- Primary DI / UDI-DI
- 00842768004896 FDA UDI
- 510(k) Number
- K033525 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
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Dimension® MALB Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microalbumin IVD, calibrator.
- ARCHITECT — ABBOTT IRELAND · Class II
- ARCHITECT — Abbott · Class I
- Autokit Micro Albumin Calibrator Set — FUJIFILM WAKO PURE CHEMICAL CORPORATION · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Pointe Scientific, Inc. Microalbumin Calibrator — POINTE SCIENTIFIC, INC. · Class II
- Chemistry UALB Calibrator Kit — Medica Corp. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
Cleared under the same submission
K033525 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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 15fd2bf0-0340-498c-8a11-861f5d5f92d5 37 fields · synced Jun 8, 2026