FDA.reportPublic FDA data

BioPlex 2200

Primary DI
00847865002226
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
SW4 V2
Catalog number
6651270C
Device description
EBV IgG Assay Protocol File CD, SW4_v2
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSEEPSTEIN-BARR VIRUS, OTHER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSEEpstein-Barr Virus, OtherMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865002226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865002226008478650022268478650022260847865002226

GMDN Terms#

Term, Definition table
TermDefinition
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Epstein-Barr virus (EBV) in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723TechSupport.USSD@bio-rad.com

Regulatory Flags#

DUNS number
884513334
Device count
1
Lot or batch
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
04048474027945Epstein Barr Virus VCA IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSE2023-08-29
04048474027969EBV-EA IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSE2023-08-29
00840239027948Epstein Barr Virus VCA IgM ELISADRG International IncLSE2023-08-24
00840239027962EBV-EA IgG ELISADRG International IncLSE2023-08-24
00847865011167Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LSE2023-01-22
03610522051243Bio-RadBio-RAD Laboratories, Inc.LSE2023-01-21
00847865010788Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LSE2023-01-04
00847865010795Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LSE2023-01-04
B3507206000Gold Standard Diagnostics Is-EBV-VCA IgG Test KitGold Standard Diagnostics CorporationLSE2022-12-07
B3507206100Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit Gold Standard Diagnostics CorporationLSE2022-12-07
B3507206500Gold Standard Diagnostics Is-EBV-EA-D IgM Test KitGold Standard Diagnostics CorporationLSE2022-12-07
00840733103247MERIFLUOR EBV-EA IgG IFAMERIDIAN BIOSCIENCE, INC.LSE2020-12-09
B3507206300Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test KitGold Standard Diagnostics CorporationLSE2020-07-27
05391516746564Bio-Rad PlateliaCLARK LABORATORIES, INC.LSE2019-11-14
05391516746540Bio-Rad PlateliaCLARK LABORATORIES, INC.LSE2019-11-07
05391516743365Trinity BiotechCLARK LABORATORIES, INC.LSE2019-11-05
05391516746953Trinity BiotechCLARK LABORATORIES, INC.LSE2019-11-05
05391516743334Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516743556Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516746946Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516747080Trinity BiotechCLARK LABORATORIES, INC.LSE2019-10-25
05391516747196PlateliaCLARK LABORATORIES, INC.LSE2019-08-06
00817273020327DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00817273020334DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00817273020341DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00817273020365DiamedixDIAMEDIX CORPORATIONLSE2016-09-20
00813545025595EBV-EA IgG 120 Test Kit SCIMEDX CORPORATIONLSE2016-09-20
00813545025618EBV EA 10 Well; 10 pk SCIMEDX CORPORATIONLSE2016-09-20
00847865000161BioPlex 2200BIO-RAD LABORATORIES, INC.LSE2016-09-12
00847865002127BioPlex 2200BIO-RAD LABORATORIES, INC.LSE2016-09-12