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K-ASSAY® Cystatin C Calibrator
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref KAI-099C
Identity
- Trade Name
- K-ASSAY Cystatin C Calibrator EUDAMEDK-ASSAY® Cystatin C Calibrator FDA UDI
- Generic Name
- Cystatin C IVD, calibrator FDA UDI
- Device Name
- Cystatin C Calibrator EUDAMEDFor the calibration of the K-ASSAY® Cystatin C assay. FDA UDI
- Model / Reference
- KAI-099C EUDAMEDFDA UDI
- Description
- For the calibration of the K-ASSAY® Cystatin C assay. FDA UDI
Identifiers
- Catalog Number
- KAI-099C FDA UDI
- Primary DI / UDI-DI
- 00816426020771 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00816426020771 EUDAMED
- 510(k) Number
- K093137 FDA UDI
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W0102019008 CYSTATIN C EUDAMED
- GMDN Term
- Cystatin C IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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: Cystatin C IVD, calibrator
K-ASSAY® Cystatin C Calibrator by Kamiya Biomedical Company, Llc — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cystatin C IVD, calibrator.
- CYSTATIN C CALIBRATOR (CYSC CAL) — Randox Laboratories, Ltd. · Class II
- Yumizen C1200 Cystatin C Cal — Horiba Abx · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Dako — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- ADVIA Cystatin C_2 Calibrator — Siemens Healthcare Diagnostics · Class II
- CYSC CAL — Randox Laboratories, Ltd. · Class II
- Cystatin C Calibrators — Sentinel Ch. Srl · Class II
- Atellica CH CYSC_2 Calibrators — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kamiya Biomedical Company, Llc
Sources (2)
- FDA UDI 9705f775-9b80-479d-a7d3-2899015fe17d 37 fields · synced Sep 30, 2026
- EUDAMED bf822b8c-e24f-4fef-a58b-c0a2d4908dc4 61 fields · synced Jul 8, 2026