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Vitek 2 AST-ST02

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 8309562

by Biomerieux , Inc.

Identity

Trade Name
VITEK® 2 AST-ST02 EUDAMEDFDA UDI
Generic Name
General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Device Name
VITEK® 2 AST-ST02 EUDAMED
The VITEK® 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus FDA UDI
Model / Reference
8309562 EUDAMED
VITEK® 2 AST-ST02 FDA UDI
Description
The VITEK® 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus FDA UDI

Identifiers

Primary DI / UDI-DI
03573026554613 EUDAMEDFDA UDI
Basic UDI-DI
357302BUDI000031SM EUDAMED
510(k) Number
K110106 FDA UDI
K111599 FDA UDI
K111893 FDA UDI
K111909 FDA UDI
K111976 FDA UDI
K112000 FDA UDI
K112075 FDA UDI
K112129 FDA UDI
K112228 FDA UDI
K121100 FDA UDI
K121863 FDA UDI
K122359 FDA UDI
K131779 FDA UDI
K132573 FDA UDI
FDA Product Code
LON FDA UDI
EMDN Code
W0104080108 GRAM POSITIVE SUSCEPTIBILITY TESTING - AUTOMATED EUDAMED
GMDN Term
General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI

Classification

Device Class
Class B EUDAMED
Class II FDA UDI
Regulation Number
866.1645 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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-St02 is a general-microorganism antimicrobial susceptibility culture medium. It is a non-selective culture medium intended to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen, specifically for S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus.

This device is intended for use with Vitek 2 Systems and is supplied as a single-use product. It must be stored in an environment between 2 and 8 degrees Celsius and is subject to IVDR authorization. The labeling does not contain MRI safety information.

Similar devices

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

Cleared under the same submission

K110106 also covers:

Frequently asked questions

What is the intended use of the VITEK 2 AST-ST02?

This device is a non-selective culture medium designed to perform diagnostic antimicrobial susceptibility testing on specific microorganisms, including S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus, when used in conjunction with VITEK 2 Systems.

Is the VITEK 2 AST-ST02 intended for reuse?

No, this device is supplied as a single-use product. It is designed to be used once for diagnostic testing and should be disposed of according to standard laboratory protocols after use.

How should the VITEK 2 AST-ST02 be stored?

To maintain the integrity of the culture medium, the product must be stored in a controlled environment between 2 and 8 degrees Celsius.

What is the regulatory status of this device?

The VITEK 2 AST-ST02 is subject to IVDR authorization, which governs its use as an in vitro diagnostic medical device.

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-ST02 The VITEK® 2 Streptococcus… - FDA.report, Biomerieux , Inc. Vitek® 2 Ast-st02 Vitek® 2 Ast-st02

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 f6ab7233-263e-4da2-bff9-6fe189527a0e 35 fields · synced Sep 27, 2026
  • EUDAMED db1e69ed-3175-48a6-957b-15bec67385f4 61 fields · synced Jul 12, 2026