Identity
- Trade Name
- mALB FDA UDI
- Generic Name
- Microalbumin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- A Microalbumin test system is a device intended for the quantitative in vitro determination of Microalbumin concentration in urine FDA UDI
- Model / Reference
- MA3828 FDA UDI
- Description
- A Microalbumin test system is a device intended for the quantitative in vitro determination of Microalbumin concentration in urine FDA UDI
Identifiers
- Catalog Number
- MA3828 FDA UDI
- Primary DI / UDI-DI
- 05055273204568 FDA UDI
- 510(k) Number
- K002674 FDA UDI
- FDA Product Code
- DDZ FDA UDI
- GMDN Term
- Microalbumin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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, kit, nephelometry/turbidimetry
mALB by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microalbumin IVD, kit, nephelometry/turbidimetry.
- Dimension® Flex® reagent cartridge MALB — Siemens Healthcare Diagnostics · Class II
- AU — Beckman Coulter, Inc. · Class II
- AU — BECKMAN COULTER IRELAND INC. · Class II
- Human Microalbumin Kit for use on SPAPLUS — The Binding Site Group · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Atellica CH uALB_2 — Siemens Healthcare Diagnostics · Class I
- VITROS — Ortho-Clinical Diagnostics · Class II
- Alinity — Abbott · Class I
Cleared under the same submission
K002674 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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI d3c901d7-2bf8-41ae-a5ce-f8f746d01db8 37 fields · synced May 30, 2026