FDA.reportPublic FDA data

BioPlex 2200

Primary DI
00847865002172
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
SW4.1_V2
Catalog number
6653360F
Device description
Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4.1_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
MXJEnzyme linked immunosorbent assay, herpes simplex virus, hsv-1
MYFEnzyme linked immunosorbent assay, herpes simplex virus, hsv-2

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1Microbiology2
MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865002172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865002172008478650021728478650021720847865002172

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) 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 herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) 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
00380740197742AlinityAbbott Ireland DiagnosticsMYF2025-10-14
00380740213893AlinityAbbott Ireland DiagnosticsMYF2025-10-14
00380740213909AlinityAbbott Ireland DiagnosticsMYF2025-10-14
00816870024332HSV 1+2 IgG AccuLite® CLIA Test System (6775-300A, 6775-300B)MONOBIND, INC.MXJ2024-09-13
00816870024363HSV 1+2 IgM AccuBind® ELISA Test System (6825-300A, 6825-300B)MONOBIND, INC.MXJ2024-09-13
00816870024370HSV 1+2 IgM AccuLite® CLIA Test System (6875-300A, 6875-300B)MONOBIND, INC.MXJ2024-09-13
00380740197704AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00380740213879AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00380740213886AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00850054026088AccuDiag ™Diagnostic Automation, Inc.MYF2023-06-27
00850054026095AccuDiag ™Diagnostic Automation, Inc.MXJ2023-06-27
07613336170656Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2022-12-06
07613336170663Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2022-12-06
07613336170687Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2022-12-06
07613336170694Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2022-12-06
00842768022784Atellica IM Herpes-1 IgGSiemens Healthcare Diagnostics Inc.MXJ2022-10-28
00842768022807Atellica IM Herpes-2 IgGSiemens Healthcare Diagnostics Inc.MYF2022-10-28
03610522051076Bio-RadBio-RAD Laboratories, Inc.MXJ2019-05-28
03610522051236Bio-RadBio-RAD Laboratories, Inc.MYF2019-05-28
00630414016726ADVIA Centaur Herpes-2 IgGSiemens Healthcare Diagnostics Inc.MYF2019-04-09
00630414016740ADVIA Centaur Herpes-1 IgGSiemens Healthcare Diagnostics Inc.MXJ2019-04-09
10816101022356DxSelect™ - 10X Wash BufferDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022363HSV-1 IgG Antigen WellsDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022370HSV-2 IgG Antigen WellsDIASORIN MOLECULAR LLCMYF2017-07-11
10816101022387HerpeSelect ELISA Sample DiluentDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022301DxSelect™ - Stop ReagentDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022295DxSelect™ - Substrate ReagentDIASORIN MOLECULAR LLCMXJ2017-07-11
04015630940431Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2017-04-21
04015630940448Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2017-04-21
00850487007135ReQuestQUEST INTERNATIONAL, INC.MXJ2016-11-30