BD Leucocount 662416

GUDID 00382906624161

Leucocount RBC Control

BECTON, DICKINSON AND COMPANY

Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control White blood cell count IVD, control

• Primary Device ID: 00382906624161
• NIH Device Record Key: ff4ada61-e463-49dc-a7e2-6cd6c55529a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Leucocount
• Version Model Number: 662416
• Catalog Number: 662416
• 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: true
• 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
• 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
• 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	00382906624161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK150307

FDA Product Code

• JPK: Mixture, hematology quality control
• OYE: Flow cytometric reagents and accessories.

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-01
• Device Publish Date: 2017-08-30

On-Brand Devices [BD Leucocount]

• 00382906624185: Leucocount Combo Control
• 00382906624178: Leucocount PLT Control
• 00382906624161: Leucocount RBC Control
• 00382906624154: Leucocount Kit w/Trucount Tubes - IVD