FDA.reportPublic FDA data

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

Primary DI
03573026600426
Brand
CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood
Company
BIOMERIEUX SA
Model
CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sh
Device description
This product consists of two culture media, dispensed into one Petri dish containing separate compartments. It is intended for use with urine specimens
Published
2020-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JXAKIT, SCREENING, URINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXAKit, Screening, UrineMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026468545PackageGS12In Commercial Distribution
03573026600426PrimaryGS10
03573026600433Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026468545035730264685453573026468545
03573026600426035730266004263573026600426
03573026600433035730266004333573026600433

GMDN Terms#

Term, Definition table
TermDefinition
Multiple formulation agar culture medium IVDA combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
276816717
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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03573026600389CHROMID® CPS® Elite Agar (CPSE)BIOMERIEUX SAJXA2020-05-19
03573026600402CHROMID® CPS® Elite Agar (CPSO)BIOMERIEUX SAJXA2020-05-19
03573026443900CHROMID® CPS® Elite Agar (CPSE)BIOMERIEUX SAJXA2020-05-19
03573026468170CHROMID® CPS® Elite Agar (CPSO)BIOMERIEUX SAJXA2020-05-19