FDA.reportPublic FDA data

Liquichek

Primary DI
00847661002987
Brand
Liquichek
Company
BIO-RAD LABORATORIES, INC.
Model
761
Catalog number
761
Device description
Liquichek Hematology-16 Control Low (A human whole blood assayed hematology control.)
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
K902389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902389000TRI-COUNT 16Hematronix, Inc.1990-08-22JCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847661002987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661002987008476610029878476610029870847661002987

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-6737qsd.techservice@bio-rad.com

Regulatory Flags#

DUNS number
051624070
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

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
00847661002994LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00847661003007LiquichekBIO-RAD LABORATORIES, INC.JCN2016-09-12
00380740017101CELL-DYNABBOTT LABORATORIESJCN2016-06-06
00380740017118CELL-DYNABBOTT LABORATORIESJCN2016-06-06