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URIC ACID Kit
EUDAMEDClass IVD General (EU MDR)
Ref B28296Model URIC ACID Kit 120mLRef B34295Model URIC ACID Kit 150mLRef B30295Model URIC ACID Kit 448mLRef B21295Model Uric Acid 432 mLRef B30296Model URIC ACID Kit 240mLRef B24296Model URIC ACID Kit 250mLRef B33296Ref B27295Model URIC ACID Kit 448mL Ref B35295Ref B22295Model Uric Acid 230 mL
Identity
- Trade Name
- URIC ACID Kit EUDAMEDURIC ACID EUDAMED
- Device Name
- URIC ACID Kit EUDAMEDUric Acid EUDAMED
- Model / Reference
- URIC ACID Kit 120mL EUDAMEDB28296 EUDAMEDURIC ACID Kit 150mL EUDAMEDB34295 EUDAMEDURIC ACID Kit 448mL EUDAMEDB30295 EUDAMEDUric Acid 432 mL EUDAMEDB21295 EUDAMEDURIC ACID Kit 240mL EUDAMEDB30296 EUDAMEDURIC ACID Kit 250mL EUDAMEDB24296 EUDAMEDB33296 EUDAMEDB27295 EUDAMEDB35295 EUDAMEDUric Acid 230 mL EUDAMEDB22295 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555619327 EUDAMED08683555600172 EUDAMED08683555614698 EUDAMED08683555611031 EUDAMED08683555601476 EUDAMED08683555601704 EUDAMED08683555616272 EUDAMED08683555601322 EUDAMED08683555617668 EUDAMED08683555612281 EUDAMED
- Basic UDI-DI
- B-08683555619327 EUDAMEDB-08683555600172 EUDAMEDB-08683555614698 EUDAMEDB-08683555611031 EUDAMEDB-08683555601476 EUDAMEDB-08683555601704 EUDAMEDB-08683555616272 EUDAMEDB-08683555601322 EUDAMEDB-08683555617668 EUDAMEDB-08683555612281 EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMEDW01010204 UREA/BLOOD UREA NITROGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Category: Uric acid IVD, reagent
URIC ACID Kit by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — Class IVD General — IVDD — listed in EUDAMED — 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
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- Uric acid — Kalians Corporation · IVD General
- ACE — Alfa Wassermann, Inc. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08683555619327 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (10)
- EUDAMED ca135b00-2996-4303-92c4-e5d3e5b78fe2 61 fields · synced Aug 3, 2026
- EUDAMED dcef7342-d559-4cfd-98b4-1572d085cae2 61 fields · synced May 16, 2026
- EUDAMED 0bc2ba66-27dc-4278-b8e6-507e8aef4f30 61 fields · synced May 17, 2026
- EUDAMED 29a11d8c-ac53-412c-b81a-f1861e9b40f1 61 fields · synced May 17, 2026
- EUDAMED 3ec30ef9-be70-4f7a-bbea-e8c027ad293c 61 fields · synced May 17, 2026
- EUDAMED 30257114-beb8-41f4-b2c0-73b25889602a 61 fields · synced May 18, 2026
- EUDAMED 23a9588a-dc72-4f55-a375-238a8000aba9 61 fields · synced May 18, 2026
- EUDAMED 4ea39e0d-9c79-4af8-ad8f-c3a618f82a7a 61 fields · synced May 19, 2026
- EUDAMED 324121f1-7640-4f2e-befa-83d8b223265d 61 fields · synced May 19, 2026
- EUDAMED 6ae97e8d-2125-46ee-9846-79e6c7c178a1 61 fields · synced May 19, 2026