FDA.reportPublic FDA data

OLO Control Kit

Primary DI
B787OCK10
Brand
OLO Control Kit
Company
S.D. SIGHT DIAGNOSTICS LTD
Model
OCK1
Device description
An in vitro diagnostic control reagent designed to monitor values on the Sight OLO multi-parameter hematology analyser.
Published
2020-05-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B787OCK10PrimaryHIBCC0

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 Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
534144402
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B787OLOU10Sight OLOOLO-U12020-02-09
B787TK10OLO CBC Test KitTK12020-02-09

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
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
00380740017118CELL-DYNABBOTT LABORATORIESJCN2016-06-06