CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA)

FDA UDI

Class I (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name: CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA) FDA UDI
Generic Name: Multiple formulation agar culture medium IVD FDA UDI
Device Name: This product consists of two culture media, dispensed into one Petri dish containing separate compartments. It is intended for use with urine specimens FDA UDI
Model / Reference: CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA) FDA UDI
Description: This product consists of two culture media, dispensed into one Petri dish containing separate compartments. It is intended for use with urine specimens FDA UDI

Identifiers

Primary DI / UDI-DI: 03573026600426 FDA UDI
FDA Product Code: JXA FDA UDI
GMDN Term: Multiple formulation agar culture medium IVD 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

Category: Multiple formulation agar culture medium IVD

CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA) by Biomerieux , Inc. — Class I — FDA UDI — listed in FDA GUDID

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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 I	Pending data

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Manufacturer

Manufacturer: Biomerieux , Inc.

Sources (1)

FDA UDI f2aec207-bdab-4aa2-9de4-48d76e00dcaf 34 fields · synced May 30, 2026