Identity
- Trade Name
- BIOBASE FDA UDI
- Generic Name
- Apolipoprotein A-I (Apo A1) IVD, reagent FDA UDI
- Model / Reference
- R1:48mL×2 R2:32mL×1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971674860877 FDA UDI
- FDA Product Code
- MSJ FDA UDI
- GMDN Term
- Apolipoprotein A-I (Apo A1) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — FDA UDI — listed in FDA GUDID — 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 8ec9719c-b3d6-4efe-b80b-5e884ac5edf6 32 fields · synced May 31, 2026