Identity
- Trade Name
- Uric Acid (UA) Test Kit (TBHBA) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Uric acid IVD, reagent FDA UDI
- Device Name
- Uric Acid (UA) Test Kit (TBHBA) EUDAMED
- Model / Reference
- R1:64mL×2 R2:16mL×2（701） EUDAMEDR1:64mL×2 R2:16mL×2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674863908 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674863908 EUDAMED
- FDA Product Code
- KNK FDA UDI
- EMDN Code
- W01010232 URIC ACID EUDAMED
- GMDN Term
- Uric acid IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1775 FDA UDI
- Market of Registration
- Germany 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
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Uric acid IVD, reagent
Biobase by Biobase Biodustry(Shandong)Co., Ltd. — Class I — IVDD, FDA UDI — listed in FDA GUDID, 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
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- Liquick Cor-UA 120 — PZ CORMAY Spółka Akcyjna · IVD General
- URIC ACID Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- Uric acid — Kalians Corporation · IVD General
- ACE — Alfa Wassermann, Inc. · Class I
- Uric Acid Assay Kit (Oxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong)Co., Ltd.
Sources (2)
- FDA UDI fd18e8b2-29ac-41ee-af32-3028b7dc2b91 32 fields · synced Jul 15, 2026
- EUDAMED 3d8a0811-3476-4be4-b114-8013dc47de8f 61 fields · synced Jul 15, 2026