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Api® 20 C Aux

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
API® 20 C AUX FDA UDI
Generic Name
Multiple Candida/yeast species culture isolate identification IVD, kit FDA UDI
Device Name
API 20 C AUX is a system for the precise identification of the most frequently encountered yeasts. FDA UDI
Model / Reference
20210 FDA UDI
Description
API 20 C AUX is a system for the precise identification of the most frequently encountered yeasts. FDA UDI

Identifiers

Primary DI / UDI-DI
03573026048082 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Api® 20 C Aux 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 a3b6a6af-a509-458b-bc21-273bc54d6b61 34 fields · synced Jun 8, 2026