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Uric Acid Reagent (URIC 2 x 300)
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 442785
Identity
- Trade Name
- Uric Acid Reagent (URIC 2 x 300) EUDAMEDSynchron FDA UDI
- Generic Name
- Uric acid IVD, kit, spectrophotometry FDA UDI
- Device Name
- Uric Acid Reagent (URIC 2 x 300) EUDAMEDFDA UDI
- Model / Reference
- 442785 EUDAMEDFDA UDI
- Description
- Uric Acid Reagent (URIC 2 x 300) FDA UDI
Identifiers
- Catalog Number
- 442785 FDA UDI
- Primary DI / UDI-DI
- D-442785QA EUDAMED15099590575281 FDA UDI
- Basic UDI-DI
- B-442785QA EUDAMED
- FDA Product Code
- KNK FDA UDI
- EMDN Code
- W01010232 URIC ACID EUDAMED
- GMDN Term
- Uric acid IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1775 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
Yes
FDA UDI
Category: Uric acid IVD, reagent
Uric Acid Reagent (URIC 2 x 300) by Beckman Coulter, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uric acid IVD, reagent.
- URIC ACID REAGENT KIT（URICASE METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Uric Acid (UA) — Maccura Biotechnology Co., Ltd. · IVD General
- Liquick Cor-UA 120 — PZ CORMAY Spółka Akcyjna · IVD General
- URIC ACID Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- Uric acid — Kalians Corporation · IVD General
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-442785QA | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (2)
- EUDAMED ac8f96a3-0f2c-46f7-876d-460bae07b4a6 61 fields · synced Jun 18, 2026
- FDA UDI a5e10b38-c861-4e4a-93fc-cc2f3591e03f 34 fields · synced May 30, 2026