← Back to catalogue

Vitek® 2 Anc

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VITEK® 2 ANC FDA UDI
Generic Name
Multiple anaerobic bacteria species culture isolate identification IVD, kit FDA UDI
Device Name
The VITEK® 2 ANC Identification Card is intended for use with the VITEK 2 Systems for ID of clinically important anaerobic bacteria and coryneform bacteria FDA UDI
Model / Reference
VITEK® 2 ANC FDA UDI
Description
The VITEK® 2 ANC Identification Card is intended for use with the VITEK 2 Systems for ID of clinically important anaerobic bacteria and coryneform bacteria FDA UDI

Identifiers

Primary DI / UDI-DI
03573026529727 FDA UDI
FDA Product Code
JSP FDA UDI
GMDN Term
Multiple anaerobic 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 anaerobic bacteria species culture isolate identification IVD, kit

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

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI 75822c7b-2350-45e9-9147-de9c211e3de5 34 fields · synced May 30, 2026