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DensiCHEK™ plus

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
DensiCHEK™ plus FDA UDI
Generic Name
Photometer, absorbance/transmission, automated FDA UDI
Device Name
The DensiCHEK™ Plus instrument is designed for use with the VITEK®2 System to measure the optical density of a microorganism suspension. FDA UDI
Model / Reference
21250 FDA UDI
Description
The DensiCHEK™ Plus instrument is designed for use with the VITEK®2 System to measure the optical density of a microorganism suspension. FDA UDI

Identifiers

Primary DI / UDI-DI
03573026222239 FDA UDI
510(k) Number
K083536 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

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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Photometer, absorbance/transmission, automated

DensiCHEK™ plus by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Photometer, absorbance/transmission, automated.

Cleared under the same submission

K083536 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI b65a4cca-04b7-4202-9843-549715fa88a9 35 fields · synced May 30, 2026