K-ASSAY® Cystatin C Control

FDA UDI

Class I (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name: K-ASSAY® Cystatin C Control FDA UDI
Generic Name: Plasma protein IVD, control FDA UDI
Device Name: For use as a consistent test sample of known concentration for monitoring assay conditions for cystatin C. FDA UDI
Model / Reference: K100C-4M FDA UDI
Description: For use as a consistent test sample of known concentration for monitoring assay conditions for cystatin C. FDA UDI

Identifiers

Catalog Number: K100C-4M FDA UDI
Primary DI / UDI-DI: 00816426020917 FDA UDI
510(k) Number: K093137 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Plasma protein IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Plasma protein IVD, control

K-ASSAY® Cystatin C Control by Kamiya Biomedical Company, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Plasma protein IVD, control.

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DImension Vista® Protein 1 Control H (high) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH — Phadia GmbH · Class I
DImension Vista® Cystatin C Control H (high) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
EliA CCP Positive Control 100 — Phadia GmbH · Class II

Cleared under the same submission

K093137 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 I	Pending data

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Manufacturer

Manufacturer: Kamiya Biomedical Company, Llc

Sources (1)

FDA UDI b2e1ed8a-f6aa-4f58-95f8-5253fdc5b23e 37 fields · synced Jun 6, 2026