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Vitek® 2 Ast-Xn19

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VITEK® 2 AST-XN19 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-XN19 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
03573026628116 FDA UDI
510(k) Number
K040845 FDA UDI
K072038 FDA UDI
K110106 FDA UDI
K121546 FDA UDI
K152075 FDA UDI
K161217 FDA UDI
K161437 FDA UDI
K163563 FDA UDI
K183551 FDA UDI
K193572 FDA UDI
FDA Product Code
LTT FDA UDI
LON FDA UDI
LTW FDA UDI
GMDN Term
General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1640 FDA UDI
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

Vitek® 2 Ast-Xn19 by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K040845 also covers:

K072038 also covers:

K110106 also covers:

K121546 also covers:

K152075 also covers:

K161217 also covers:

K161437 also covers:

K163563 also covers:

K183551 also covers:

K193572 also covers:

N50510 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI e4cee3ba-aead-4ec1-8e45-6fa5b17620be 35 fields · synced May 30, 2026