Identity
- Trade Name
- ALB FDA UDI
- Generic Name
- Albumin IVD, reagent FDA UDI
- Device Name
- An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma. FDA UDI
- Model / Reference
- AB362 FDA UDI
- Description
- An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma. FDA UDI
Identifiers
- Catalog Number
- AB362 FDA UDI
- Primary DI / UDI-DI
- 05055273200041 FDA UDI
- 510(k) Number
- K984494 FDA UDI
- FDA Product Code
- CIX FDA UDI
- GMDN Term
- Albumin IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1035 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: Albumin IVD, reagent
Alb by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Albumin IVD, reagent.
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Albumin BCP (6x50 mL) — Sentinel Ch. Srl · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Albumin -BCG method TC-Matrix — TECO DIAGNOSTICS · Class II
- Ricca Chemical Company® — RICCA CHEMICAL COMPANY LLC · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class II
Cleared under the same submission
K984494 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 6064fc3c-df5e-4b2b-8a55-5077bc3d506c 37 fields · synced May 30, 2026