Vitek®2 Ast-Gn89

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name: VITEK®2 AST-GN89 FDA UDI
Generic Name: General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Device Name: VITEK ® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli FDA UDI
Model / Reference: VITEK®2 AST-GN89 FDA UDI
Description: VITEK ® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli FDA UDI

Identifiers

Primary DI / UDI-DI: 03573026531102 FDA UDI
510(k) Number: K041982 FDA UDI
K072038 FDA UDI
K091899 FDA UDI
K110106 FDA UDI
K113200 FDA UDI
FDA Product Code: LON FDA UDI
GMDN Term: General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.1645 FDA UDI
Commercial Distribution: Not 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

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

Vitek®2 Ast-Gn89 by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

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 78ee8a39-e7ef-4c1b-af29-65f4b13a1d31 36 fields · synced Jun 1, 2026