Identity
- Trade Name
- MICROALBUMIN (mALB) FDA UDI
- Generic Name
- Microalbumin IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- MA8056 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273209242 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
No
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: Microalbumin IVD, kit, nephelometry/turbidimetry
MICROALBUMIN (mALB) by Randox Laboratories, Ltd. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Microalbumin IVD, kit, nephelometry/turbidimetry.
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- Atellica CH uALB_2 — Siemens Healthcare Diagnostics · Class I
- VITROS — Ortho-Clinical Diagnostics · Class II
- Alinity — Abbott · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002674 | Class II | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (2)
- FDA UDI 7a787dd1-2f82-4b4c-bbfc-a37f3458709a 56 fields · synced Jun 18, 2026
- FDA 510(k) K002674 1 fields · synced Jun 4, 2026