CHROMID® CPS® Elite Agar (CPSO)

GUDID 03573026468170

Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms

BIOMERIEUX SA

Differential/selective agar culture medium IVD

• Primary Device ID: 03573026468170
• NIH Device Record Key: 7bbdcfea-bc16-4596-bf9d-d442f5449756
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHROMID® CPS® Elite Agar (CPSO)
• Version Model Number: CHROMID® CPS® Elite Agar (CPSO)
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026443917 [Package]; Contains: 03573026600402; Package: [10 Units]; In Commercial Distribution
GS1	03573026468170 [Package]; Contains: 03573026600402; Package: [2 Units]; In Commercial Distribution
GS1	03573026600402 [Primary]
GS1	03573026600419 [Unit of Use]

FDA Product Code

• JXA: KIT, SCREENING, URINE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-19
• Device Publish Date: 2020-05-19

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• 03573026443900 - CHROMID® CPS® Elite Agar (CPSE): 2026-01-19 Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms
• 03573026468170 - CHROMID® CPS® Elite Agar (CPSO): 2026-01-19Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms
• 03573026468170 - CHROMID® CPS® Elite Agar (CPSO): 2026-01-19 Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms