BD™ Multi-Check 340916

GUDID 00382903409167

BD Multi-Check CD4 Low Ctrl 5X2.5mL IVD

BECTON, DICKINSON AND COMPANY

CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent immunoassay, rapid CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) CD4 cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

• Primary Device ID: 00382903409167
• NIH Device Record Key: f9e33729-c7f1-419e-9fa4-0f2f42797a66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD™ Multi-Check
• Version Model Number: 340916
• Catalog Number: 340916
• Company DUNS: 024230633
• Company Name: BECTON, DICKINSON AND COMPANY
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com

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
• 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
• 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	00382903409167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982231

FDA Product Code

• GKZ: Counter, differential cell

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-08

On-Brand Devices [BD™ Multi-Check]

• 00382903409167: BD Multi-Check CD4 Low Ctrl 5X2.5mL IVD
• 00382903409150: BD Multi-Check CD4 Low Ctrl 2X2.5mL IVD
• 00382903409143: BD Multi-Check CD4 Low Ctrl 1X2.5mL IVD
• 00382903409136: BD Multi-Check Control 5X2.5mL IVD
• 00382903409129: BD Multi-Check Control 2X2.5mL IVD
• 00382903409112: BD Multi-Check Control 1X2.5mL IVD