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VITEK 2 AST-N809 Gram Negative Susceptibility Card

FDA UDIEUDAMED

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VITEK® 2 AST-N809 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 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli FDA UDI
Model / Reference
VITEK® 2 AST-N809 FDA UDI
Description
VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli FDA UDI

Identifiers

Primary DI / UDI-DI
03573026635961 FDA UDI
510(k) Number
K040845 FDA UDI
K072038 FDA UDI
K091899 FDA UDI
K110106 FDA UDI
K113200 FDA UDI
K152075 FDA UDI
K161217 FDA UDI
K161227 FDA UDI
K162737 FDA UDI
K163563 FDA UDI
K172731 FDA UDI
K211630 FDA UDI
K222073 FDA UDI
K222378 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
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General-microorganism antimicrobial susceptibility culture medium IVD

The VITEK 2 AST-N809 is a non-selective culture medium classified as a general-microorganism antimicrobial susceptibility testing device. It is designed for automated antimicrobial susceptibility testing of clinically significant aerobic gram-negative bacilli isolated from clinical specimens, enabling rapid and standardized antimicrobial resistance profiling.

This single-use, non-sterile card is intended for use exclusively with the VITEK 2 Systems. It requires storage at temperatures between 2°C and 8°C and includes an expiration date. The device is regulated under the In Vitro Diagnostic Regulation (IVDR) and is supplied in packages containing 20 units, with each unit bearing a lot or batch number. No MRI safety information is provided, and it is not intended for direct patient marking.

Similar devices

Also classified as General-microorganism antimicrobial susceptibility culture medium IVD.

Cleared under the same submission

K040845 also covers:

K072038 also covers:

K091899 also covers:

K110106 also covers:

K113200 also covers:

K152075 also covers:

K161217 also covers:

K161227 also covers:

K162737 also covers:

K163563 also covers:

K172731 also covers:

K211630 also covers:

K222073 also covers:

K222378 also covers:

N50510 also covers:

Frequently asked questions

What is the VITEK® 2 AST-N809 used for?

The VITEK® 2 AST-N809 is a non-selective culture medium designed exclusively for automated antimicrobial susceptibility testing of clinically significant aerobic gram-negative bacilli. It helps laboratories rapidly and accurately determine bacterial resistance profiles, aiding in targeted antibiotic treatment decisions for patient care.

How is the VITEK® 2 AST-N809 supplied and stored?

The device is supplied in packages containing 20 single-use, non-sterile cards. Each card includes a lot or batch number for traceability. Storage requires refrigeration between 2°C and 8°C, and the product has an expiration date clearly marked on the packaging.

Is the VITEK® 2 AST-N809 sterile or reusable?

The VITEK® 2 AST-N809 is not sterile and is intended for single-use only. It is not designed for reuse or reprocessing, ensuring consistent and reliable antimicrobial susceptibility testing results with each use.

What regulatory pathway does the VITEK® 2 AST-N809 follow?

This device is regulated under the In Vitro Diagnostic Regulation (IVDR) in the EU. It is classified as a general-microorganism antimicrobial susceptibility testing culture medium and has undergone premarket submissions (e.g., K040845, K072038) to demonstrate its safety, performance, and compliance with regulatory standards.

Can the VITEK® 2 AST-N809 be used with any microbiology system?

No, the VITEK® 2 AST-N809 is exclusively compatible with the VITEK 2 Systems. It is not designed for use with other automated microbiology platforms, as its functionality relies on the specific integration and software algorithms of the VITEK 2 System.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VITEK® 2 AST-N809 VITEK® 2 Gram Negative… - FDA.report, Biomerieux , Inc. Vitek® 2 Ast-n809 Vitek® 2 Ast-n809, Vitek® 2 Ast-n809 - Beudamed

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (2)

  • FDA UDI 196320b5-5750-40f4-ad7d-aed8bbb84b22 35 fields · synced Oct 1, 2026
  • EUDAMED 1 fields · synced Jun 11, 2026