BD 349703

GUDID 00382903497034

Multi-Check CD4 Low Ctrl 1X2.5mL US-IVD DI 00382903497034, BD MultiCheck CD4 Low Ctrl Vial UDI DI 00382903497077

BECTON, DICKINSON AND COMPANY

CD4 cell marker IVD, kit, fluorescent immunoassay, rapid
Primary Device ID00382903497034
NIH Device Record Key9e7ff11b-b79e-4987-b3f6-e64c8a6ef943
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD
Version Model Number349703
Catalog Number349703
Company DUNS024230633
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382903497034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, differential cell
JPKMixture, hematology quality control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-25

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00382906629951Multitest 6-color TBNK w/Trucount US-IVD
00382906629678Multitest 6-color TBNK Reagent US-IVD
00382906629654Multitest IMK Kit 50 Tests US-IVD
00382906629616Kit FC Beads 7 Color US IVD
00382906624147CST beads 150T IVD DI (01) 00382906624147, CS&T beads (generic IVD) DI (01) 00382906626493
00382906624130CST beads 50T IVD
00382903497058Multi-Check CD4 Low Ctrl 5X2.5mL US-IVD DI 00382903497058, BD MultiCheck CD4 Low Ctrl Vial UDI D
00382903497041Multi-Check CD4 Low Ctrl 2X2.5mL US-IVD DI 00382903497041, BD MultiCheck CD4 Low Ctrl Vial UDI D
00382903497034Multi-Check CD4 Low Ctrl 1X2.5mL US-IVD DI 00382903497034, BD MultiCheck CD4 Low Ctrl Vial UDI D
00382903497027Multi-Check Control 5X2.5mL US-IVD DI 00382903497027, BD MultiCheck Control Vial UDI DI 00382903
00382903497010Multi-Check Control 2X2.5mL US-IVD DI 00382903497010, BD MultiCheck Control Vial UDI DI 00382903
00382903497003Multi-Check Control 1X2.5mL US-IVD

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