FDA.reportPublic FDA data

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

Primary DI
03573026468545
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
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290006418111DIASLIDE URINE CULTURING DEVICESAVYON DIAGNOSTICS LTDJXA2026-05-04
07290013348531URISCREEN SAVYON DIAGNOSTICS LTDJXA2026-04-29
50885380070271CARDINAL HEALTHCardinal Health 200, LLCJXA2024-02-28
00860008737359Know Rapid STD TestMobiLab Medical Innovatives Inc.JXA2024-02-06
00860008737304MobiLab Standard Sexual Health Self Rapid TestMobiLab Medical Innovatives Inc.JXA2024-02-05
00613647003596FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003602FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
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20613647003712FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
03573026600389CHROMID® CPS® Elite Agar (CPSE)BIOMERIEUX SAJXA2020-05-19
03573026600402CHROMID® CPS® Elite Agar (CPSO)BIOMERIEUX SAJXA2020-05-19
03573026600426CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep bloodBIOMERIEUX SAJXA2020-05-19
03573026443900CHROMID® CPS® Elite Agar (CPSE)BIOMERIEUX SAJXA2020-05-19