FDA.reportPublic FDA data

Bio-Rad Laboratories, Inc.

Primary DI
00847865011174
Brand
Bio-Rad Laboratories, Inc.
Company
Bio-RAD Laboratories, Inc.
Model
25190
Catalog number
25190
Device description
Wash Concentrate for Serology EIA Tests
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
LFZENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFZEnzyme Linked Immunoabsorbent Assay, CytomegalovirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954191000SERAQUEST CMV IGGQuest Intl., Inc.1996-02-23LFZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865011174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865011174008478650111748478650111740847865011174

GMDN Terms#

Term, Definition table
TermDefinition
Buffered wash solution IVD, manualA buffered wash solution intended to be used in combination with other IVDs during the manual processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume30Milliliter

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)224-6723TechSupport.USSD-Redmond@bio-rad.com

Regulatory Flags#

DUNS number
844766394
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
00816870024240CMV IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFZ2024-09-13
00816870024257CMV IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFZ2024-09-13
00816870024288CMV IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFZ2024-09-13
00816870024295CMV IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFZ2024-09-13
04048474027976CMV IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLFZ2023-08-29
00840239027979CMV IgG ELISA DRG International IncLFZ2023-08-24
00380740181093AlinityAbbott Ireland DiagnosticsLFZ2023-07-14
00380740181109AlinityAbbott Ireland DiagnosticsLFZ2023-07-14
07613336193082Elecsys CMV IgGRoche Diagnostics GmbHLFZ2022-12-07
07613336198469Elecsys CMV IgGRoche Diagnostics GmbHLFZ2022-12-06
00894175000558AccuDiag™Diagnostic Automation, Inc.LFZ2021-11-29
00894175000053AccuDiag ™ Diagnostic Automation, Inc.LFZ2021-08-10
B3507203200Gold Standard Diagnostics Is-CMV IgG ELISA Test KitGold Standard Diagnostics CorporationLFZ2020-06-03
05391516746885Trinity BiotechCLARK LABORATORIES, INC.LFZ2019-12-27
00630414588872ADVIA Centaur CMV IgGSiemens Healthcare Diagnostics Inc.LFZ2019-02-10
00630414246635Atellica IM CMV IgGSiemens Healthcare Diagnostics Inc.LFZ2018-11-30
03610520150269BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
03610521167488BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
03610520992715BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
04015630940172Elecsys CMV IgGRoche Diagnostics GmbHLFZ2017-04-21
04015630940189Elecsys CMV IgMRoche Diagnostics GmbHLFZ2017-04-17
08056771101943LIAISON® CMV IgMDIASORIN SPALFZ2016-09-24
00630414961231IMMULITE® 2000 Systems CVG CMV IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFZ2016-09-24
00630414963822IMMULITE®/IMMULITE® 1000 Systems CMV CMV IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFZ2016-09-24
05391516745024Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-22
05391516745031Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-22
05391516743419Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
05391516743426Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
05391516746991Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
04015630937172Elecsys CMV IgG AssayRoche Diagnostics GmbHLFZ2016-09-20