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Vitek® 2 Ast-Xn32

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 543422

by Biomerieux , Inc.

Identity

Trade Name
VITEK® 2 AST-XN32 EUDAMEDFDA UDI
Generic Name
General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Device Name
VITEK® 2 AST-XN32 EUDAMED
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
543422 EUDAMED
VITEK® 2 AST-XN32 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
03573026635473 EUDAMEDFDA UDI
Basic UDI-DI
357302BUDI002159TW EUDAMED
510(k) Number
K032861 FDA UDI
K040845 FDA UDI
K121546 FDA UDI
K152075 FDA UDI
K161437 FDA UDI
K161510 FDA UDI
K163006 FDA UDI
K163083 FDA UDI
K172944 FDA UDI
K183360 FDA UDI
K183551 FDA UDI
K193572 FDA UDI
FDA Product Code
LON FDA UDI
EMDN Code
W0104080107 GRAM NEGATIVE 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
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

No

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

Vitek® 2 Ast-Xn32 by Biomerieux , Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K032861 also covers:

K040845 also covers:

K121546 also covers:

K152075 also covers:

K161437 also covers:

K161510 also covers:

K163006 also covers:

K163083 also covers:

K172944 also covers:

K183360 also covers:

K183551 also covers:

K193572 also covers:

N50510 also covers:

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 e9e39c5e-06a9-437c-804e-9c47edd17489 35 fields · synced Jul 17, 2026
  • EUDAMED 87e8142f-11de-4190-902d-f17055de045e 61 fields · synced Jul 17, 2026