IMMULITE® Systems CVG CONTROL CMV IgG

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name: IMMULITE® Systems CVG CONTROL CMV IgG FDA UDI
Generic Name: Cytomegalovirus (CMV) antigen IVD, control FDA UDI
Device Name: CMV IgG - IMMULITE - CTL FDA UDI
Model / Reference: 10469595 FDA UDI
Description: CMV IgG - IMMULITE - CTL FDA UDI

Identifiers

Catalog Number: LCVGCM FDA UDI
Primary DI / UDI-DI: 00630414976709 FDA UDI
510(k) Number: K950672 FDA UDI
FDA Product Code: LIP FDA UDI
GMDN Term: Cytomegalovirus (CMV) antigen IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3830 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: Cytomegalovirus (CMV) antigen IVD, control

IMMULITE® Systems CVG CONTROL CMV IgG by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K950672 also covers:

IMMULITE®/IMMULITE® 1000 Systems CMV CMV IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

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: Siemens Healthcare Diagnostics Products Ltd

Sources (1)

FDA UDI 59be2e79-e49f-4f95-8ea6-7c97b4e3cdaf 37 fields · synced May 30, 2026