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)

• 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