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Vitek® 2 Yst

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VITEK® 2 YST FDA UDI
Generic Name
Multiple Candida/yeast species culture isolate identification IVD, kit FDA UDI
Device Name
The VITEK® 2 YST Identification Card is intended for use with the VITEK 2 to determine ID of clinically important yeast and yeast-like organisms FDA UDI
Model / Reference
VITEK® 2 YST FDA UDI
Description
The VITEK® 2 YST Identification Card is intended for use with the VITEK 2 to determine ID of clinically important yeast and yeast-like organisms FDA UDI

Identifiers

Primary DI / UDI-DI
03573026529697 FDA UDI
FDA Product Code
JXB FDA UDI
GMDN Term
Multiple Candida/yeast 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 Candida/yeast species culture isolate identification IVD, kit

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

Similar devices

Also classified as Multiple Candida/yeast 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 a0a2904f-87f0-41ab-9b63-a126d907cbdc 34 fields · synced Jun 8, 2026