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API® M Medium

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
API® M Medium FDA UDI
Generic Name
Multiple Enterobacteriaceae species culture isolate identification IVD, reagent FDA UDI
Device Name
API M Medium allows the differentiation between motile and non-motile bacteria of the facultative aero-anaerobic group. It can be used to complement the API 20 E strip. FDA UDI
Model / Reference
API® M Medium FDA UDI
Description
API M Medium allows the differentiation between motile and non-motile bacteria of the facultative aero-anaerobic group. It can be used to complement the API 20 E strip. FDA UDI

Identifiers

Primary DI / UDI-DI
03573026588687 FDA UDI
FDA Product Code
JSH FDA UDI
GMDN Term
Multiple Enterobacteriaceae species culture isolate identification IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2320 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

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 Enterobacteriaceae species culture isolate identification IVD, reagent

API® M Medium by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Enterobacteriaceae species culture isolate identification IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI f41a96d1-e469-40f2-b5a4-ec065ab0243b 34 fields · synced May 29, 2026