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Simplexa Congenital CMV Positive Control Pack

FDA UDI

Class II (US FDA UDI)

by DiaSorin Molecular LLC

Identity

Trade Name
Simplexa Congenital CMV Positive Control Pack FDA UDI
Generic Name
Cytomegalovirus (CMV) nucleic acid IVD, control FDA UDI
Model / Reference
MOL2265 FDA UDI

Identifiers

Catalog Number
MOL2265 FDA UDI
Primary DI / UDI-DI
20816101025842 FDA UDI
510(k) Number
K202755 FDA UDI
FDA Product Code
QDZ FDA UDI
OOI FDA UDI
GMDN Term
Cytomegalovirus (CMV) nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3181 FDA UDI
862.2570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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: Cytomegalovirus (CMV) nucleic acid IVD, control

Simplexa Congenital CMV Positive Control Pack by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cytomegalovirus (CMV) nucleic acid IVD, control.

Cleared under the same submission

K202755 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DiaSorin Molecular LLC

Sources (1)

  • FDA UDI 3a6c7bcb-a96f-4a5e-8d18-1d5672bd71fb 36 fields · synced Jun 9, 2026