BD 662414

GUDID 00382906624147

CST beads 150T IVD DI (01) 00382906624147, CS&T beads (generic IVD) DI (01) 00382906626493

BECTON, DICKINSON AND COMPANY

Flow cytometer calibration/verification solution IVD Flow cytometer calibration/verification solution IVD Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use Optical laboratory instrument performance standard calibrator/control IVD, single-use

• Primary Device ID: 00382906624147
• NIH Device Record Key: f4a41518-02c5-4a1e-8f0b-6de91a4dffe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD
• Version Model Number: 662414
• Catalog Number: 662414
• 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
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• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
• Phone: +1(877)232-8995
• Email: BDBCustomerService@bd.com
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• Email: BDBCustomerService@bd.com
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• 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
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• Email: BDBCustomerService@bd.com
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• Email: BDBCustomerService@bd.com
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• Email: BDBCustomerService@bd.com
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• Email: BDBCustomerService@bd.com
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• Email: BDBCustomerService@bd.com
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• Email: BDBCustomerService@bd.com
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• Email: BDBCustomerService@bd.com
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• 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
• 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	00382906624147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK150307

FDA Product Code

• 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-30

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• 00382906629654: Multitest IMK Kit 50 Tests US-IVD
• 00382906629616: Kit FC Beads 7 Color US IVD
• 00382906624147: CST beads 150T IVD DI (01) 00382906624147, CS&T beads (generic IVD) DI (01) 00382906626493
• 00382906624130: CST beads 50T IVD
• 00382903497058: Multi-Check CD4 Low Ctrl 5X2.5mL US-IVD DI 00382903497058, BD MultiCheck CD4 Low Ctrl Vial UDI D
• 00382903497041: Multi-Check CD4 Low Ctrl 2X2.5mL US-IVD DI 00382903497041, BD MultiCheck CD4 Low Ctrl Vial UDI D
• 00382903497034: Multi-Check CD4 Low Ctrl 1X2.5mL US-IVD DI 00382903497034, BD MultiCheck CD4 Low Ctrl Vial UDI D
• 00382903497027: Multi-Check Control 5X2.5mL US-IVD DI 00382903497027, BD MultiCheck Control Vial UDI DI 00382903
• 00382903497010: Multi-Check Control 2X2.5mL US-IVD DI 00382903497010, BD MultiCheck Control Vial UDI DI 00382903
• 00382903497003: Multi-Check Control 1X2.5mL US-IVD