CELL-DYN 04H6003

GUDID 00380740007317

CELL-DYN 3200

ABBOTT LABORATORIES

Haematological cell analyser IVD, automated Haematological cell analyser IVD, automated Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD
Primary Device ID00380740007317
NIH Device Record Key6d22e168-4f1c-4110-a6d2-da24a29c645f
Commercial Distribution Discontinuation2018-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCELL-DYN
Version Model Number04H60-03
Catalog Number04H6003
Company DUNS079226220
Company NameABBOTT LABORATORIES
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx
Phone+1(877)422-2688
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100380740007317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, differential cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-23
Device Publish Date2016-09-09

On-Brand Devices [CELL-DYN]

00380740020996CELL-DYN 1800 System DETERGENT
00380740001148CELL-DYN Sapphire System WBC REAGENT - PART B
00380740001131CELL-DYN Sapphire System WBC REAGENT - PART A
00380740120788CELL-DYN Emerald 22 Diluent
00380740120771CELL-DYN Emerald 22 Lyse
00380740120764CELL-DYN Emerald 22 Easy Cleaner
00380740119843CELL-DYN 22 Plus Calibrator
00380740119836CELL-DYN 22 Plus Control
00380740119829CELL-DYN 22 Plus Control
00380740099916CELL-DYN Ruby
00380740072643CELL-DYN 1800 System CN-FREE DIFF LYSE
00380740072445CELL-DYN 1800 System DILUENT
00380740071141CELL-DYN 1800
00380740021085ENZYM CLNR 2X50 ML
00380740021016CELL-DYN 3700 System HGB / WIC LYSE
00380740020989CELL-DYN 3700 System DETERGENT
00380740020972CELL-DYN 1800 System DETERGENT
00380740020965CELL-DYN 3700 SHEATH
00380740020958CELL-DYN 3700 System DILUENT
00380740020941CELL-DYN 1800 System DILUENT
00380740020347CELL-DYN 18 PLUS CALIBRATOR
00380740020330CELL-DYN 18 PLUS CONTROL
00380740020323CELL-DYN 18 PLUS CONTROL
00380740020286CELL-DYN EMERALD 22
00380740020156CELL-DYN Emerald DILUENT
00380740020149CELL-DYN Emerald CN-FREE LYSE
00380740020132CELL-DYN Emerald CLEANER
00380740020088CELL-DYN Emerald
00380740017170CELL-DYN Ruby
00380740017149CELL-DYN RETIC PLUS CONTROL
00380740017118CELL-DYN 26 PLUS CONTROL
00380740017101CELL-DYN 26 PLUS CONTROL
00380740017095CELL-DYN 29 PLUS CONTROL (with Retic)
00380740017088CELL-DYN 29 PLUS CONTROL (with Retic)
00380740017071CELL-DYN HemCal Plus Calibrator
00380740017026CELL-DYN Ruby, CELL-DYN 3200 Systems WBC LYSE
00380740016623CELL-DYN Sapphire
00380740016616CELL-DYN Sapphire
00380740013547CELL-DYN 1800 System CN-FREE DIFF LYSE
00380740013493CELL-DYN 1800
00380740013356CELL-DYN Immuno T-Cell (CD3/4/8) Reagents
00380740007317CELL-DYN 3200
00380740007300CELL-DYN 3200
00380740007270CELL-DYN 3200
00380740007263CELL-DYN 3200
00380740005160CELL-DYN Ruby, CELL-DYN 3200 System CN-FREE HGB/NOC LYSE
00380740005153CELL-DYN 3200 System DILUENT/SHEATH
00380740005146CELL-DYN 3200 WBC LYSE
00380740005115CELL-DYN 3700 System CN-FREE HGB / WIC LYSE
00380740005009CELL-DYN RETICULOCYTE REAGENT

Trademark Results [CELL-DYN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CELL-DYN
CELL-DYN
73387624 1298458 Live/Registered
Sequoia-Turner Corporation
1982-09-22

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