DImension Vista® High Sensitivity CRP Control H (high)

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name: DImension Vista® High Sensitivity CRP Control H (high) FDA UDI
Generic Name: C-reactive protein (CRP) IVD, control FDA UDI
Device Name: For use as an assayed intralaboratory control for assessment of precision and analytical bias in the determination of the hsCRP method on the Dimension Vista® System FDA UDI
Model / Reference: 10445930 FDA UDI
Description: For use as an assayed intralaboratory control for assessment of precision and analytical bias in the determination of the hsCRP method on the Dimension Vista® System FDA UDI

Identifiers

Catalog Number: KC757 FDA UDI
Primary DI / UDI-DI: 00842768006432 FDA UDI
510(k) Number: K061802 FDA UDI
FDA Product Code: JJY FDA UDI
GMDN Term: C-reactive protein (CRP) 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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: C-reactive protein (CRP) IVD, control

DImension Vista® High Sensitivity CRP Control H (high) by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as C-reactive protein (CRP) IVD, control.

ASI CRP Control Set — Arlington Scientific, Inc. · Class II
K-ASSAY® hsCRP Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
HIGH SENSITIVITY CRP CONTROL - LEVEL II (hsCRP CONTROL 2) — Randox Laboratories, Ltd. · Class I
Audit MicroControls Linearity LQ hs-CRP — Aalto Scientific, Ltd.
Diazyme — Diazyme Laboratories, Inc.
POINTE SCIENTIFIC CRP Control Set — POINTE SCIENTIFIC, INC. · Class II
ARCHITECT — Abbott Laboratories, Inc. · Class I
Audit MicroControls Linearity LQ hsCRP for Ortho Vitros — Aalto Scientific, Ltd.

Cleared under the same submission

K061802 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: Siemens Healthcare Diagnostics Products Ltd

Sources (1)

FDA UDI 0239debc-1dcd-415e-89b9-0eb5eaf4d2f0 37 fields · synced Jun 8, 2026