BD Multitest 6-Color Assays 663007

GUDID 00382906630070

Bundle SW FACSuite Multitest 6c US IVD

BECTON, DICKINSON AND COMPANY

Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory analyser operation system software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD

• Primary Device ID: 00382906630070
• NIH Device Record Key: f841b448-5386-4d3e-9a4f-b481df03bba3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Multitest 6-Color Assays
• Version Model Number: 663007
• Catalog Number: 663007
• 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: false
• Serial Number: false
• 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(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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382906630070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170974

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: 2018-01-10

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 50382903649902 - BD Vacutainer® Urinalysis Transfer Straw Kit: 2024-04-18 KIT URIN TRANSTR 16X100 10.0 UA YEL
• 50382903649445 - BD Vacutainer® C&S Boric Acid Kit: 2024-04-17 KIT URIN PLH 16X100 10 C&S KAGN CE
• 50382903649599 - BD Vacutainer® C&S Boric Acid Kit: 2024-04-17 KIT URIN TRANSTR 13X75 C&S KAGN CE HEMO
• 50382903649919 - BD Vacutainer® Urinalysis Transfer Straw Kit: 2024-04-17 KIT URIN TRANSTR 16X100 8.0 CONI UA YEL
• 50382903686556 - BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder: 2024-04-16 Wingset SLBCS 23x.75 7 Preattached
• 50382903689205 - BD Vacutainer® FX 5mg 4mg Blood Collection Tubes: 2024-04-16 TUBE GLU PLH 13X75 2.0 BLBLCE GR
• 50382903689212 - BD Vacutainer® FX 10mg 8mg Blood Collection Tubes: 2024-04-16 TUBE GLU 13X75 4.0 PLH PLBLCE GR
• 50382903649575 - BD Vacutainer® Urine Complete Cup Kit: 2024-04-15 KIT URIN COMP 13X75 C&S 16X100 CONI UAP