FDA.reportPublic FDA data

BioPlex 2200

Primary DI
00847865002189
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
SW 4_2
Catalog number
6652465F
Device description
U.S. IFU, Manual & CDs, BioPlex 2200, MMRV IgG IFU, 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
LFYENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER
LJBEnzyme linked immunoabsorbent assay, rubeola IgG
LJYENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS
OPLMultiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFYEnzyme Linked Immunoabsorbent Assay, Varicella-ZosterMicrobiology2
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola IggMicrobiology1
LJYEnzyme Linked Immunoabsorbent Assay, Mumps VirusMicrobiology1
OPLMultiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster VirusMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865002189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865002189008478650021898478650021890847865002189

GMDN Terms#

Term, Definition table
TermDefinition
Varicella-zoster virus (VZV) 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 varicella-zoster virus (VZV) in a clinical specimen, using a fluorescent immunoassay method.

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
03573026644796VIDAS® Varicella-Zoster IgGBIOMERIEUX SALFY2026-01-19
00850054026156QMedix™Diagnostic Automation, Inc.LJB2025-06-05
ENTIMEAG03300NovaLisa Measles Virus IgGGold Standard Diagnostics Frankfurt GmbHLJB2024-08-26
ENTIMUMG03400NovaLisa Mumps Virus IgGGold Standard Diagnostics Frankfurt GmbHLJY2024-08-26
ENTIMEAG0330NovaLisa Measles Virus IgGGold Standard Diagnostics Frankfurt GmbHLJB2024-08-26
ENTIMUMG0340NovaLisa Mumps Virus IgGGold Standard Diagnostics Frankfurt GmbHLJY2024-08-26
00840239038470Mumps IgM ELISADRG International IncLJY2024-08-20
04048474038477Mumps IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJY2024-08-20
B347VP5938800001Vanity PlanetLED TECHNOLOGIES INCOPL2024-03-13
00850054026019QMedix™Diagnostic Automation, Inc.OPL2024-02-02
08033891322434CHORUS MEASLES IgGDIESSE DIAGNOSTICA SENESE SPALJB2024-01-22
08033891322458CHORUS MUMPS IgGDIESSE DIAGNOSTICA SENESE SPALJY2024-01-22
04048474059670Measles Virus IgG Avidity ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2023-09-01
04048474028089Varicella Zoster Virus (VZV) IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLFY2023-08-29
00840239059673Measles Virus IgG Avidity ELISADRG International IncLJB2023-08-26
00840239028082Varicella Zoster Virus (VZV) IgG ELISA DRG International IncLFY2023-08-24
00850049545396AccuDiag ™Diagnostic Automation, Inc.LJB2023-06-14
00847865010764Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LJB2023-01-22
00847865010771Bio-Rad LaboratoriesBio-RAD Laboratories, Inc.LJY2023-01-04
00894175000039AccuDiag ™ Diagnostic Automation, Inc.OPL2021-08-10
00894175000060AccuDiag ™ Diagnostic Automation, Inc.LJY2021-08-10
00404847459678Measles Virus IgG Avidity ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJB2021-06-07
B3507205400Gold Standard Diagnostics Is-Mumps IgG ELISA Test KitGold Standard Diagnostics CorporationLJY2020-07-27
B3507203800Gold Standard Diagnostics Is-VZV IgG ELISA Test KitGold Standard Diagnostics CorporationLFY2020-05-20
B3507205200Gold Standard Diagnostics Is-Measles IgG ELISA Test KitGold Standard Diagnostics CorporationLJB2020-05-20
05391516746755Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516746793Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516746830Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516743600Trinity BiotechCLARK LABORATORIES, INC.LJY2019-10-25
05391516743631Trinity BiotechCLARK LABORATORIES, INC.LJB2019-10-25