Identity
- Trade Name
- K-ASSAY® hsCRP Calibrator FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, calibrator FDA UDI
- Device Name
- For the calibration of the K-ASSAY® hsCRP assay. FDA UDI
- Model / Reference
- KAI-161C FDA UDI
- Description
- For the calibration of the K-ASSAY® hsCRP assay. FDA UDI
Identifiers
- Catalog Number
- KAI-161C FDA UDI
- Primary DI / UDI-DI
- 00816426020757 FDA UDI
- FDA Product Code
- JIT FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 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: C-reactive protein (CRP) IVD, calibrator
K-ASSAY® hsCRP Calibrator by Kamiya Biomedical Company, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, calibrator.
- ADVIA® Chemistry Wide Range C-Reactive Protein Calibrators — Siemens Healthcare Diagnostics · Class II
- CRP Ultra WR Calibrator — Sekisui Diagnostics, LLC · Class II
- ABX Pentra CRP HS Cal — Horiba Abx · Class II
- CRP CAL — Randox Laboratories, Ltd. · Class II
- POINTE SCIENTIFIC CRP Calibrator Set (5, 20, 40, 160, 320 mg/L) — POINTE SCIENTIFIC, INC. · Class II
- CRP CAL — Randox Laboratories, Ltd. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- hsCRP CAL — Randox Laboratories, Ltd. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kamiya Biomedical Company, Llc
Sources (1)
- FDA UDI 13322fcd-4e88-48d9-853c-f57c9cf69ac2 36 fields · synced Jun 8, 2026