Bact/Alert®

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name: BACT/ALERT® FDA UDI
Generic Name: Blood culture broth kit IVD FDA UDI
Device Name: Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of a variety of anaerobic and facultative microorganisms FDA UDI
Model / Reference: BACT/ALERT® FDA UDI
Description: Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of a variety of anaerobic and facultative microorganisms FDA UDI

Identifiers

Primary DI / UDI-DI: 03573026616694 FDA UDI
FDA Product Code: GIM FDA UDI
MDB FDA UDI
GMDN Term: Blood culture broth kit IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1675 FDA UDI
866.2560 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Blood culture broth kit IVD

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

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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 f5a458b2-e818-4673-9a4d-09d3549c381f 34 fields · synced May 31, 2026