CHROMID® CARBA agar

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name: CHROMID® CARBA agar FDA UDI
Generic Name: Differential/selective agar culture medium IVD FDA UDI
Device Name: Selective and differential chromogenic medium for screening of rectal swabs for carbapenemase-producing Escherichia coli and Klebsiella pneumoniae. FDA UDI
Model / Reference: CHROMID® CARBA agar FDA UDI
Description: Selective and differential chromogenic medium for screening of rectal swabs for carbapenemase-producing Escherichia coli and Klebsiella pneumoniae. FDA UDI

Identifiers

Primary DI / UDI-DI: 03573026597719 FDA UDI
510(k) Number: K181092 FDA UDI
FDA Product Code: JSO FDA UDI
GMDN Term: Differential/selective agar culture medium IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.1700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Differential/selective agar culture medium IVD

CHROMID® CARBA agar by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Differential/selective agar culture medium IVD.

REMEL — REMEL, INC. · Class I
REMEL — REMEL, INC. · Class I
REMEL — REMEL, INC. · Class I
OxyPRAS Plus KVL plate — Oxyrase, Inc. · Class I
REMEL — REMEL, INC. · Class I
PRAS Porphyromonas gingivalis Agar (P.GING) — Anaerobe Systems · Class I
REMEL — REMEL, INC. · Class I
REMEL — REMEL, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Biomerieux , Inc.

Sources (1)

FDA UDI dd8e002f-cfc5-44be-8d90-ada32574676a 35 fields · synced May 30, 2026