BD MAX Check-Points CPO 278102

GUDID 00180002781029

BD MAX Check-Points CPO contains: 24 each, Master Mix, Reagent Strips, Extraction Tubes, Sample Buffer Tubes, Septum Caps. The BD MAX Check-Points CPO Assay detects the presence of carbapenemase genes in Gram-negative bacteria and includes an internal Sample Processing Control.

Check-Points Health B.V.

Multiple antimicrobial resistance nucleic acid IVD, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00180002781029
• NIH Device Record Key: 11a432cd-000f-4312-b9ee-1f9d2b04020e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD MAX Check-Points CPO
• Version Model Number: 278102
• Catalog Number: 278102
• Company DUNS: 409613986
• Company Name: Check-Points Health B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00180002781029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190613

FDA Product Code

• POC: System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-11
• Device Publish Date: 2019-11-01