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API® 50 CHL Medium

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
API® 50 CHL Medium FDA UDI
Generic Name
Multiple aerobic gram positive bacteria species culture isolate identification IVD, reagent FDA UDI
Device Name
API 50 CHL Medium, for ID of Lactobacillus and related genera, is a ready-to-use allowing fermentation of the 49 carbohydrates on the API 50 CH strip (Ref. 50 300). FDA UDI
Model / Reference
API® 50 CHL Medium FDA UDI
Description
API 50 CHL Medium, for ID of Lactobacillus and related genera, is a ready-to-use allowing fermentation of the 49 carbohydrates on the API 50 CH strip (Ref. 50 300). FDA UDI

Identifiers

Primary DI / UDI-DI
03573026588717 FDA UDI
FDA Product Code
JSC FDA UDI
GMDN Term
Multiple aerobic gram positive bacteria species culture isolate identification IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2350 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 aerobic gram positive bacteria species culture isolate identification IVD, reagent

API® 50 CHL Medium by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple aerobic gram positive bacteria 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 06cc5ef6-0501-42f1-9e37-0b8f891d7905 34 fields · synced May 31, 2026