Bact/Alert

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name: BACT/ALERT FDA UDI
Generic Name: Blood culture analyser IVD FDA UDI
Device Name: R3.1 SW/FW for BACT/ALERT VIRTUO FDA UDI
Model / Reference: R3.1 FDA UDI
Description: R3.1 SW/FW for BACT/ALERT VIRTUO FDA UDI

Identifiers

Primary DI / UDI-DI: 03573026629649 FDA UDI
510(k) Number: K161816 FDA UDI
FDA Product Code: MDB FDA UDI
GMDN Term: Blood culture analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2560 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Blood culture analyser IVD

Bact/Alert by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K161816 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 I	Pending data

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Manufacturer

Manufacturer: Biomerieux , Inc.

Sources (1)

FDA UDI 0dcd50dd-a3fd-4689-aca3-535ce1c9ebfb 34 fields · synced Jun 1, 2026