FDA.reportPublic FDA data

Liquichek

Primary DI
00847661003090
Brand
Liquichek
Company
BIO-RAD LABORATORIES, INC.
Model
514
Catalog number
514
Device description
Liquichek Sedimentation Rate Control Level 1 (A human whole blood assayed erythrocyte sedimentation rate control.)
Published
2017-01-12
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
JPHTEST, ERYTHROCYTE SEDIMENTATION RATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPHTest, Erythrocyte Sedimentation RateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847661003090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661003090008476610030908476610030900847661003090

GMDN Terms#

Term, Definition table
TermDefinition
Erythrocyte sedimentation rate (ESR) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius30 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
Premarket exempt
true
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
00810160810414Red TunicaRodimedi & Associates, Inc.JPH2025-03-14
10810160810411Red TunicaRodimedi & Associates, Inc.JPH2025-03-14
00860011967712ZELLESR-10STERILE SAFEQUIP & CHEMICALS LLPJPH2024-07-07
00840095624572Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095682404Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095624565Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
00840095682411Globe ScientificGLOBE SCIENTIFIC INC.JPH2023-07-05
04038917088138ESR pipette without graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917135047ESR pipette with graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917085205ESR rack for Monovette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917085304ESR rack for S-Sedivette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917085311ESR rack for Microvette®Sarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917169943ESR pipette without graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
04038917207607ESR pipette with graduationSarstedt Aktiengesellschaft & Co.KGJPH2022-11-30
08033891321017ESR ControlDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
08033891321048ESR ControlDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
08033891328207ESR Control CubeDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
08033891328757ESR Control CubeDIESSE DIAGNOSTICA SENESE SPAJPH2022-11-25
29120017578172VacuetteGreiner Bio-One GmbHJPH2020-09-30
29120017578189VacuetteGreiner Bio-One GmbHJPH2020-09-30
39120017578179VacuetteGreiner Bio-One GmbHJPH2020-09-30
39120017578186VacuetteGreiner Bio-One GmbHJPH2020-09-30
29120017578158VacuetteGreiner Bio-One GmbHJPH2020-09-25
39120017578155VacuetteGreiner Bio-One GmbHJPH2020-09-25
07612964013106DISPETTE®Guest Scientific AGJPH2020-06-01
07612964013113DISPETTE®Guest Scientific AGJPH2020-06-01
07612964000762DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013304DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013328DISPETTE®Guest Scientific AGJPH2019-11-07
07612964013403DISPETTE®Guest Scientific AGJPH2019-11-07