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Vitek® 2 Ast-N804

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VITEK® 2 AST-N804 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-N804 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
03573026634780 FDA UDI
510(k) Number
K072038 FDA UDI
K091899 FDA UDI
K103752 FDA UDI
K110106 FDA UDI
K113200 FDA UDI
K161227 FDA UDI
K161510 FDA UDI
K162737 FDA UDI
K163006 FDA UDI
K163083 FDA UDI
K163563 FDA UDI
K172731 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

Vitek® 2 Ast-N804 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

K072038 also covers:

K091899 also covers:

K103752 also covers:

K110106 also covers:

K113200 also covers:

K161227 also covers:

K161510 also covers:

K162737 also covers:

K163006 also covers:

K163083 also covers:

K163563 also covers:

K172731 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 261e5abe-c315-4e2f-8ec8-d66bdbb2e6b0 35 fields · synced Jun 8, 2026