Identity
- Trade Name
- K-ASSAY® Apo B Reagent FDA UDI
- Generic Name
- Apolipoprotein B (Apo B) IVD, reagent FDA UDI
- Device Name
- For the quantitative determination of human apolipoprotein B (Apo B) in serum by immunoturbidimetric assay. FDA UDI
- Model / Reference
- KAI-004 FDA UDI
- Description
- For the quantitative determination of human apolipoprotein B (Apo B) in serum by immunoturbidimetric assay. FDA UDI
Identifiers
- Catalog Number
- KAI-004 FDA UDI
- Primary DI / UDI-DI
- 00816426020030 FDA UDI
- 510(k) Number
- K993354 FDA UDI
- FDA Product Code
- DER FDA UDI
- GMDN Term
- Apolipoprotein B (Apo B) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Apolipoprotein B (Apo B) IVD, reagent
K-ASSAY® Apo B Reagent by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, reagent.
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Lipoprotein (a) — Diagam S.A. · IVD General
- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Apolipoprotein B Reagent (ApoB 2 x 100) — Beckman Coulter, Inc. · IVD General
- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Lipoprotein (a) Kit (Latex-Enhanced Immunoturbidimetric Method) — MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. · IVD General
- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology 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 II | Pending data |
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Manufacturer
- Manufacturer
- Kamiya Biomedical Company, Llc
Sources (1)
- FDA UDI c25e6b80-a4d3-4533-b2ab-81385f9962f2 37 fields · synced Jun 7, 2026