BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application 444908

GUDID 00382904449087

BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application

BD Kiestra B.V.

Histology/cytology/microbiology image-analysis interpretive software IVD

• Primary Device ID: 00382904449087
• NIH Device Record Key: 42fe838b-ab6f-4b61-a65d-2e15b735d4e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application
• Version Model Number: 444908
• Catalog Number: 444908
• Company DUNS: 417876166
• Company Name: BD Kiestra 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com
• Phone: +1(800)638-8663
• Email: Technical_services@bd.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904449087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213280

FDA Product Code

• QQY: Culture plate imaging system for qualitative assessment of resistant organisms

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: 2025-12-25
• Device Publish Date: 2025-12-17

Devices Manufactured by BD Kiestra B.V.

• 00382904449087 - BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application: 2025-12-25BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application
• 00382904449087 - BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application: 2025-12-25 BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application
• 00382904469733 - BD Kiestra™ InoqulA: 2025-02-26 BD Kiestra™ InoqulA
• 00382904460969 - BD Kiestra™ Regular Base: 2023-10-31 BD Kiestra™ Regular Base
• 00382904460976 - BD Kiestra™ Main Base: 2023-10-30 BD Kiestra™ Main Base
• 00382904469443 - BD Kiestra™ U-Turn: 2023-10-30 BD Kiestra U-turn
• 00382904469467 - BD Kiestra™ Straight: 2023-10-30 BD Kiestra Straight
• 00382904460921 - BD Kiestra™ T-junction: 2023-10-27 BD Kiestra™ T-junction
• 00382904460938 - BD Kiestra™ ErgonomicA Connector R: 2023-10-27 BD Kiestra™ ErgonomicA Connector R