CHROMID® CPS® Elite Agar (CPSO)

Primary DI
03573026468170
Brand
CHROMID® CPS® Elite Agar (CPSO)
Company
BIOMERIEUX SA
Model
CHROMID® CPS® Elite Agar (CPSO)
Device description
Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms
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
03573026443917PackageGS110In Commercial Distribution
03573026468170PackageGS12In Commercial Distribution
03573026600402PrimaryGS10
03573026600419Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026443917035730264439173573026443917
03573026468170035730264681703573026468170
03573026600402035730266004023573026600402
03573026600419035730266004193573026600419

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

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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03573026559823THxID™ BRAF1.02017-05-12
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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
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

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Primary DI, Brand, Company table
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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
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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