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Vitek® 2 Gn

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VITEK® 2 GN FDA UDI
Generic Name
Multiple gram negative bacteria species culture isolate identification IVD, kit FDA UDI
Device Name
The VITEK® 2 GN Identification Card is intended for use with the VITEK 2 to determine ID of clinically important Gram negative bacteria FDA UDI
Model / Reference
VITEK® 2 GN FDA UDI
Description
The VITEK® 2 GN Identification Card is intended for use with the VITEK 2 to determine ID of clinically important Gram negative bacteria FDA UDI

Identifiers

Primary DI / UDI-DI
03573026529987 FDA UDI
FDA Product Code
LQM FDA UDI
GMDN Term
Multiple gram negative bacteria species culture isolate identification IVD, kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple gram negative bacteria species culture isolate identification IVD, kit

Vitek® 2 Gn by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple gram negative bacteria species culture isolate identification IVD, kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI 4d432f2e-1405-4497-8885-10ce11419893 34 fields · synced May 30, 2026