Identity
- Trade Name
- 5′-Nucleotidase (5’-NT) Test Kit (Colorimetric) EUDAMEDBIOBASE FDA UDI
- Generic Name
- 5-Nucleotidase IVD, reagent FDA UDI
- Device Name
- 5′-Nucleotidase (5’-NT) Test Kit (Colorimetric) EUDAMED
- Model / Reference
- R1:50mL×2 R2:25mL×2（716） EUDAMEDR1:50mL×2 R2:25mL×2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674866251 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674866251 EUDAMED
- FDA Product Code
- CED FDA UDI
- EMDN Code
- W01010101 5'-NUCLEOTIDASE EUDAMED
- GMDN Term
- 5-Nucleotidase IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1520 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: 5-Nucleotidase 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 5-Nucleotidase IVD, reagent.
- 5′-Nucleotidase(5′-NT) Test Kit (Peroxidase Assay) — URIT Medical Electronic Co.,Ltd. · IVD General
- 5′-Nucleotidase (5'-NT) — Maccura Biotechnology Co., Ltd. · IVD General
- 5′-Nucleotidase (5'-NT) — Maccura Biotechnology Co., Ltd. · IVD General
- 5′-Nucleotidase Kit（Enzymatic Colorimetric Method） — Shenzhen Mindray Bio-Medical Electronics Co.,LTD · Class B
- 5′-Nucleotidase Kit（Enzymatic Colorimetric Method） — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class B
- 5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- 5'-Nucleotidase Reagent Kit — HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD. · IVD General
- 5′-Nucleotidase (5'-NT) — Maccura Biotechnology 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 42f905fa-bd3a-42da-9e42-64f2fe5536c2 32 fields · synced Jun 19, 2026
- EUDAMED 47221216-027d-4a60-85b2-e9f3f83e57cc 61 fields · synced Jun 19, 2026