SC-CAL PLUS Calibrator

FDA UDI

Class II (US FDA UDI)

by Shenzhen Mindray Bio-Medical Electronics Co.

Identity

Trade Name: SC-CAL PLUS Calibrator FDA UDI
Generic Name: Full blood count IVD, calibrator FDA UDI
Model / Reference: SC-CAL PLUS FDA UDI

Identifiers

Primary DI / UDI-DI: 06944904084152 FDA UDI
510(k) Number: K955925 FDA UDI
FDA Product Code: KRX FDA UDI
GMDN Term: Full blood count IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.8150 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

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

MRI Safety

MR Unsafe FDA UDI

Category: Full blood count IVD, calibrator

SC-CAL PLUS Calibrator by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K955925 also covers:

ADVIA® 360/560 Calibrator — Siemens Healthcare Diagnostics

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: Shenzhen Mindray Bio-Medical Electronics Co.

Sources (1)

FDA UDI 5fdf688e-4ea5-4120-b44c-6c06b7539670 34 fields · synced May 30, 2026