Identity
- Trade Name
- K-ASSAY® Lp(a) Reagent FDA UDI
- Generic Name
- Lipoprotein A IVD, reagent FDA UDI
- Device Name
- For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay. FDA UDI
- Model / Reference
- KAI-044 FDA UDI
- Description
- For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay. FDA UDI
Identifiers
- Catalog Number
- KAI-044 FDA UDI
- Primary DI / UDI-DI
- 00816426020245 FDA UDI
- 510(k) Number
- K021660 FDA UDI
- FDA Product Code
- DFC FDA UDI
- GMDN Term
- Lipoprotein A IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5600 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: Lipoprotein A IVD, reagent
K-ASSAY® Lp(a) Reagent by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lipoprotein A IVD, reagent.
- Pointe Scientific, Inc. Lipoprotein (a) — POINTE SCIENTIFIC, INC. · Class II
- Pointe Lp(a) Reagent — POINTE SCIENTIFIC, INC. · Class II
- Lp(a) Ultra — Sentinel Ch. Srl · Class II
- Pointe Lp(a) Reagent — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K021660 also covers:
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 4dbd2153-7307-447a-b800-dab18730557c 37 fields · synced Jun 8, 2026