FDA.reportPublic FDA data

CELL-DYN

Primary DI
00380740017118
Brand
CELL-DYN
Company
ABBOTT LABORATORIES
Model
08H59-02
Catalog number
08H5902
Device description
CELL-DYN 26 PLUS CONTROL
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCNCONTROL, CELL COUNTER, NORMAL AND ABNORMAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCNControl, Cell Counter, Normal And AbnormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901875000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901875000PARA 12 PLUSStreck Laboratories, Inc.1990-05-30JCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740017118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740017118003807400171183807400171180380740017118

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815762020490Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JCN2025-12-01
30844509000199Para 12® PlusSTRECK, INC.JCN2020-08-24
B787OCK10OLO Control KitS.D. SIGHT DIAGNOSTICS LTDJCN2020-05-04
00815762021978R & D Systems, Inc. CBC-PIX Hematology ControlRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JCN2018-12-05
00630414224367ADVIA® 120/2120/2120i TESTpoint Low ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414224381ADVIA® 120/2120/2120i TESTpoint Normal ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414224404ADVIA® 120/2120/2120i TESTpoint High ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414473390ADVIA® 120/2120/2120i 3-in-1 TESTpoint Normal ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414473406ADVIA® 120/2120/2120i 3-in-1 TESTpoint Low ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
00630414473413ADVIA® 120/2120/2120i 3-in-1 TESTpoint High ControlSiemens Healthcare Diagnostics Inc.JCN2016-09-24
20844509001144STaK-ChexSTRECK, INC.JCN2016-09-19
20844509001151STaK-ChexSTRECK, INC.JCN2016-09-19
20844509001168STaK-ChexSTRECK, INC.JCN2016-09-19
30844509001158STaK-ChexSTRECK, INC.JCN2016-09-19
00844509001171STaK-ChexSTRECK, INC.JCN2016-09-19
00844509001188STaK-ChexSTRECK, INC.JCN2016-09-19
20844509000185Para 12 PlusSTRECK, INC.JCN2016-09-14
20844509000192Para 12 PlusSTRECK, INC.JCN2016-09-14
20844509000208Para 12 PlusSTRECK, INC.JCN2016-09-14
00844509000211Para 12 PlusSTRECK, INC.JCN2016-09-14
00844509000228Para 12 PlusSTRECK, INC.JCN2016-09-14
00844509000235Para 12 PlusSTRECK, INC.JCN2016-09-14
00847661002963LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661002970LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661002987LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661002994LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661003007LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00380740017101CELL-DYNABBOTT LABORATORIESJCN2016-06-06