VITEK® DENSICHEK® Display Base

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name: VITEK® DENSICHEK® Display Base FDA UDI
Generic Name: Photometer, absorbance/transmission, automated FDA UDI
Device Name: The DISPLAY is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacterial suspension. It is used for the Vitek instrument to prepare ID and AST test. FDA UDI
Model / Reference: 422220 FDA UDI
Description: The DISPLAY is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacterial suspension. It is used for the Vitek instrument to prepare ID and AST test. FDA UDI

Identifiers

Primary DI / UDI-DI: 03573026605667 FDA UDI
510(k) Number: K192110 FDA UDI
FDA Product Code: LON FDA UDI
GMDN Term: Photometer, absorbance/transmission, automated FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.1645 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Photometer, absorbance/transmission, automated

VITEK® DENSICHEK® Display Base by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Photometer, absorbance/transmission, automated.

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MicroScan — Beckman Coulter, Inc. · Class I
VITEK® DENSICHEK® POD — BIOMERIEUX , INC. · Class II
VITEK® DENSICHEK® Connectivity Base — BIOMERIEUX , INC. · Class II
DensiCHEK™ plus — BIOMERIEUX , INC. · Class II

Cleared under the same submission

K192110 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 II	Pending data

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Manufacturer

Manufacturer: Biomerieux , Inc.

Sources (1)

FDA UDI fd12a274-2050-46c6-aef6-b2b97d79fda0 35 fields · synced May 30, 2026