Identity
- Trade Name
- Chemistry UALB Calibrator Kit FDA UDI
- Generic Name
- Microalbumin IVD, calibrator FDA UDI
- Device Name
- Microalbumin Calibrator Kit for use with EasyRA Analyzer FDA UDI
- Model / Reference
- 10656 FDA UDI
- Description
- Microalbumin Calibrator Kit for use with EasyRA Analyzer FDA UDI
Identifiers
- Catalog Number
- 10656 FDA UDI
- Primary DI / UDI-DI
- 00386100001773 FDA UDI
- 510(k) Number
- K101089 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
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
Yes
FDA UDI
Category: Microalbumin IVD, calibrator
Chemistry UALB Calibrator Kit by Medica Corp. — 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
- Atellica CH µALB_2 Calibrator — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Pointe Scientific, Inc. Microalbumin Calibrator — POINTE SCIENTIFIC, INC. · Class II
- Dimension® MALB Calibrator — Siemens Healthcare Diagnostics · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
Cleared under the same submission
K101089 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
- Medica Corp.
Sources (1)
- FDA UDI 690d799f-a6ae-46b4-a84f-3d680569315c 37 fields · synced May 30, 2026