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Biobase
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref R1:90mL×1 R2:30mL×1Model R1:90mL×1 R2:30mL×1（708）
Identity
- Trade Name
- Apolipoprotein A1 (ApoA1) Test Kit (Immunoturbidimetric) EUDAMEDBIOBASE FDA UDI
- Generic Name
- Apolipoprotein A-I (Apo A1) IVD, reagent FDA UDI
- Device Name
- Apolipoprotein A1 (ApoA1) Test Kit (Immunoturbidimetric) EUDAMED
- Model / Reference
- R1:90mL×1 R2:30mL×1 EUDAMEDFDA UDIR1:90mL×1 R2:30mL×1（708） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674860853 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971674860853 EUDAMED
- FDA Product Code
- MSJ FDA UDI
- EMDN Code
- W0102010401 APOLIPOPROTEIN A I EUDAMED
- GMDN Term
- Apolipoprotein A-I (Apo A1) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1475 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
No
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: Apolipoprotein A-I (Apo A1) 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 Apolipoprotein A-I (Apo A1) IVD, reagent.
- APOLIPOPROTEÍNA A1 — QUIMICA CLINICA APLICADA S.A. · IVD General
- Nephstar Apo A1 Kit — Goldsite Diagnostics Inc. · IVD General
- APO A1 — Medicon Hellas SA · IVD General
- Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
- Apolipoprotein A1 — Diagam S.A. · IVD General
- Apolipoprotein AⅠ (ApoAⅠ) — Maccura Biotechnology Co., Ltd. · IVD General
- Apolipoprotein A1 Reagent Kit — HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD. · IVD General
- Apolipoprotein A1 Kit (Immunoturbidimetric Assay) — Shanghai Kehua Bio-engineering 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 2940d62d-9905-4e3f-81ad-f60228231258 32 fields · synced Jul 31, 2026
- EUDAMED 9caea3be-f9f5-41f4-a99e-61e5e19bcd54 61 fields · synced Jul 31, 2026